Views: 0 Author: Site Editor Ɣeyiɣi si wotae: 2026-07-14 Dzɔtsoƒe: Teƒe
Mamãla akpa gãtɔ siwo tsɔa pedicle screw dzralawo sɔna kple wo nɔewo dzea egɔme tso unit price dzi le monoaxial kple polyaxial screws dzi, emegbe wowɔa dɔ yia megbe tso afima. Emae nye mɔ si mesɔ o si dzi woato age ɖe eme. Pedicle screw system menye nu ɖeka si wotsɔ de ame me o — enye amekoko ƒe dɔwɔwɔ blibo si wòle be wòalé ɖekae le screw tiatia, atikplɔ, kadodowo, dɔwɔnu siwo dzi ɖena kpɔtɔna, torque dziɖuɖu, sterilization trays, kple nuŋlɔɖi siwo na kɔdzi xɔa atike la kura. Ne ènya be ɖoɖo ma ƒe akpa mamlɛa wɔa dɔ ŋutɔŋutɔ ko hafi asixɔxɔ nɔa vevie.
Woŋlɔ esia koŋ na mamalawo le China-si le pedicle screw ɖoɖo wɔla aɖe me tom — nusi wòle be nàlé ŋku ɖe hafi nàwɔ nudzraɖoƒe, kple nusiwo te ŋu gblẽna ne mamalawo ti kpo tẽe yi asi tsɔtsɔ sɔ kple wo nɔewo gbɔ.
A cage nye akpa gãtɔ le eɖokui si — geometry, material, wɔ. Pedicle screw system to vovo elabena woƒoe nu ƒu le OR me tso akpa geɖe siwo katã wòle be woawɔ nu aduadu nyuie le agba te: screw si bɔbɔ nɔ ƒu me, atikplɔ si to screw tawo me, set screw si wotu ɖe anyigba le torque tɔxɛ aɖe me, connectors bridging levels alo tsɔ cross-links kpee, kple instrument set si wɔa reduction, derotation, kple tightening mamlɛtɔ.
Ne kakɛ mawo dometɔ aɖe bu le mamala ƒe agbalẽdzraɖoƒe — screw ƒe didime nyuitɔ na pedicle gbadzaa, crosslink na xɔ si le dzisasrã etɔ̃, xɔ kɔkɔ si dzi ɖena kpɔtɔna na spondylolisthesis case — amekolaa va nyaa le dɔwɔwɔ ƒe titina, ke menye le nudzadzra ƒe kaƒoƒo me o. Ema nye nɔnɔme si vɔ̃ɖi wu le ŋutilã me wu SKU si bu le agbalẽdzraɖoƒe. Enye dɔléle si tsi anyi eye dɔnɔa le atike si naa alɔ̃dɔdɔ ame xoxo.
Hafi nàɖo asixɔxɔ na naneke la, wɔ nusi tututu adzɔnuwɔƒea na la ƒe nɔnɔmetata ɖe nusi yɔ fũu ŋu megbe fixation case bia be:
Screw ƒomeviwo — monoaxial (na fixed-angle constructs, zi geɖe le deformity ɖɔɖɔɖo ƒe ta), polyaxial (le akpa gãtɔ siwo sɔ, si ɖea mɔ na dzogoe dzi mɔɖeɖe le atikplɔ ƒe zikpui dzi), reduction screws (na spondylolisthesis alo fracture dzi ɖeɖe kpɔtɔ), kple cannulated screws (na percutaneous MIS ɖoɖo ɖe mɔfianu dzi)
Atiwo — didime tiatia (5.5mm kple 6.0mm tsyɔ akpa gãtɔ megbe fixation hiahiãwo), nu (titanium akɔbli vs. cobalt-chromium na ɖeɖiteameŋu ƒe tsitretsitsi si lolo wu le xɔ didiwo me), kple didime ƒe didime
Crosslinks kple connectors — na multi-level constructs, revision cases, alo bridging le atikplɔ ƒe akpa siwo ƒe lolome to vovo dome
Dɔwɔnuwo ƒe hatsotsowo — pedicle finders, pɔmpiwo, screwdrivers, rod holders, reduction instruments, kple torque-limiting wrenches, sɔ kple ɖoɖoa ƒe ʋuʋu kple MIS tɔ siaa
Ne adzɔnuwɔƒe aɖe ate ŋu aɖe blibo aɖe afia spine implant system spanning ʋuʋu megbe fixation to MIS spinal fixation options, ema nye dzeɖoɖo si to vovo si ŋu gɔmesese le wu esi ate ŋu ayɔ screws kple rods siwo me dɔwɔnu siwo wodzrana ɖe vovo, le lead time si to vovo me, tso production line bubu me ko.
Spec sheet didi aɖe megblɔna na wò nenye be ɖoɖoa wɔa dɔ nyuie ŋutɔŋutɔ le OR la me o. Nusi le vevie ŋutɔŋutɔ kpɔkpɔ le pepa dzi sesẽ wu:
Screw ta ƒe liƒo — ɖe polyaxial ta léa eƒe dzogoe nyuie ne wonya bɔbɔ nɔ atikplɔa ko, alo ɖe wòtrɔna vie le sesẽ mamlɛtɔ me, tsɔa xɔtuɖoɖoa ƒua gbea?
Rod-to-screw fit — ɖe atikplɔa ƒe didime sɔ kple gavi la ƒe tulip-mɔa ŋutɔŋutɔa, alo ɖe fefe si sɔ gbɔ be atikplɔa naʋuʋu hafi gavi si woɖo la nayi edzia?
Set screw locking behavior — ɖokui-gbãgbã set screws (si bɔ ɖe 5.5mm ɖoɖowo) hiã na madzudzɔmadzudzɔe breakaway torque. Ne torque ma toa vovo tso hatsotso ɖeka me yi bubu me la, amekolawo mesẽna ɖe edzi le ŋuɖɔɖɔɖo ta alo gavi la megbãna dzadzɛ o, eye esia evea siaa nana nuɖanua nɔa blewu.
Dɔwɔnu ƒe asiléƒe — ɖe ʋuƒoa ƒua du ɖe gavi ƒe ta dzi le torque te, vevietɔ le dɔnɔ si goglo alo lolo akpa si amekolaa le dɔ wɔm le kple nukpɔkpɔ si dzi ɖe kpɔtɔ eye leverage didiwo dzi ɖe edzi mea?
Tray ƒe ɖoɖowɔwɔ — ɖe woɖo tray la ɖe ɖoɖo nu le mɔ si nu scrub tech si menya nu tso ɖoɖoa ŋu o ate ŋu akplɔe ɖo kokokoa, alo ɖe wòbia tso rep la si be wòazɔ to eme le nɔnɔme ɖesiaɖe mea?
Esiawoe nye nyatakaka siwo ma ɖoɖo aɖe si amekolawo ɖe mɔ ɖo la ɖa tso esi wodi ŋutɔŋutɔ gbɔ. Wo dometɔ aɖeke medzena le adzɔnu aɖe ƒe foto me o.
Esiae nye akpa si me mamalawo ƒe akpa gãtɔ medea ga boo o, eye eyae nye akpa si kpɔa tawò ne nane gblẽ ƒe etɔ̃ le kɔdzi ƒe nubabla me. Hafi nàtsɔ ɖokuiwò ana na nudzrala aɖe la, bia be:
ISO 13485 scope annex — si ɖo kpe edzi tẽe la, eƒo nu tso pedicle screw systems ŋu, menye ƒumeŋutinunya ƒe ɖaseɖigbalẽ si wotsɔ dea ƒumeŋuɖui me si dzɔna be wòdea akɔta abe hatsotso ene ko o
CE nuŋlɔɖiwo le afisi wòsɔ le na asi siwo nèɖo taɖodzinu na
Nusiwo wotsɔ wɔe ƒe ɖaseɖigbalẽwo — mill certs na titanium alloy stock, si ɖo kpe atike ƒe wɔwɔme kple mɔ̃ɖaŋununya ƒe nɔnɔmewo dzi ɖe ASTM ƒe dzidzenu si sɔ nu
Mɔ̃ɖaŋu dodokpɔ ŋuti nyatakakawo — static kple dynamic dodokpɔ le ASTM F1717 alo esi sɔ kple spinal fixation systems, si ɖee fia be xɔtutua léa dzi le simulated physiological load te
Ðeɖiteameŋu dodokpɔ ŋuti nyatakakawo — vevietɔ na atikplɔ kple gavi ƒe ƒomedodo, elabena afisiae fixation ɖoɖowo dina be yewoado kpo nu ne nu alo nuwo wɔwɔ ƒe nyonyome mewɔ ɖeka o
Traceability records — ɖe woate ŋu akplɔ screw aɖe koŋ ayi eƒe production batch kple raw material lot, ɣleti alo ƒewo le eƒe meli megbea?
Dɔwɔnuwo me dzodzro ƒe nuŋlɔɖiwo — didime ƒe kpeɖodzi le dɔwɔnu siwo dzi ɖena kpɔtɔna kple torque safuiwo ŋu, ke menye le nusiwo wotsɔ de eme la ŋutɔ dzi ko o
Le XC Medico la, woate ŋu ado alɔ pedicle screw system evaluation kple nusiwo wotsɔ kplɔa nu ɖo ƒe nuŋlɔɖiwo, batch-level mechanical testing documentation, kple product specification files bliboe hena distributor review hafi woawɔ nudɔdɔ aɖeke.
Akɔta mama akpa gãtɔ va hiãa ʋuʋu kple MIS pedicle screw tiatia siaa mlɔeba, elabena ƒã hafi kɔdzi ƒe nyawo ƒe tsakatsaka dzea akpa ɖeka keŋkeŋ. Zi geɖe la, wowɔa revision case alo multi-level deformity correction le ʋuʋu ɖi. Wole 1-2 level degenerative case si le amekokoƒe si me wowɔa dɔ geɖe le la wɔm to ŋutigbalẽ me geɖe wu.
Ne wò nudzrala wɔa ɖeka ko — ne míagblɔe la, ɖoɖo sesẽ aɖe si le ʋuʋu ɖi gake dɔwɔnu siwo wotsɔna toa ŋutigbalẽ me mele eme o — la, èwu enu be yeakpɔ MIS ɖe vovo tso dɔwɔƒe evelia gbɔ, akpɔ nudzraɖoƒe eve siwo medo ƒome o dzi, ana hehe wò nudzralawo ƒe ƒuƒoƒoa le dɔwɔnu ƒe susu vovovo eve ŋu, eye nèle mɔ kpɔm be screw geometry mahe tɔtɔ vɛ le OR ƒe ɖoƒe o.
Adzɔnuwɔƒe aɖe si le evea siaa nam ʋuʋu spinal stabilization system kple esi sɔ MIS spinal fixation system — si wotu ƒo xlã shared screw geometry kple rod specifications — ɖea mama ma ɖa. Wò agbalẽdzraɖoƒe ƒe ɖoɖowɔwɔ va zua dzeɖoɖo ɖeka tsɔ wu be wòanye nudzralawo ƒe ƒomedodo vovovo eve siwo me afɔku ŋuti nyatakaka eve vovovowo le.
Menye gavi kple atikplɔ koe mamala le ƒlem o — wole ŋutete si le esi be lolome nyuitɔ nanɔ asi me ƒlem ne kɔdzi aɖe ƒo ka kple nya aɖe si woɖo ɖi na etsɔ. Pedicle screw ɖoɖowo ƒe nɔnɔmewo keke ta (didime geɖe, didime geɖe, monoaxial kple polyaxial, standard kple cannulated), eye zi geɖe la, kɔdziwo hiãna be woatsɔ odd size mid-case akpe ɖe standard order ŋu. Ne wò nudzrala ƒe nudzraɖoƒe ƒe agbɔsɔsɔme le sue la, dometsotso ma va zua wò kuxi le ɣeyiɣi vɔ̃ɖitɔ kekeake si nàte ŋui me.
Le mamala si ge ɖe akɔta ƒe asi yeye me gome la, MOQ si bɔbɔ le vevie le susu bubu aɖe ta: taɖodzinu gbãtɔ menye be woayɔ nudzraɖoƒe aɖe o. Taɖodzinu gbãtɔe nye be nàda asi ɖe amekola ƒe lɔlɔ̃ ɖe edzi dzi, aɖo kpe edzi be nuŋlɔɖiawo sɔ ɖe wò ŋkɔ dede agbalẽ me ƒe nudidiwo nu, eye nàkpɔ kɔdzi ƒe didi ŋutɔŋutɔ hafi atsɔ ga ade asi na ɖoɖo bliboa. Le launch-stage mamalawo gome la, XC Medico ate ŋu ado alɔ pedicle screw system evaluation kple OEM/ODM spine projects tso 1 set MOQ, akpe ɖe asisiwo ŋu woada asi ɖe amekola ƒe lɔlɔ̃ ɖe edzi, nuŋlɔɖiwo ƒe sɔsɔ, kple kɔdzi didi dzi hafi adzidze nudzraɖoƒe. Nudzrala si bia nudɔdɔ suetɔ kekeake gãwo le gavi ƒe didime kple didime matriki bliboa dzi zi dziwò be nàsusu alesi wodi hafi dzesi ŋutɔŋutɔ aɖeke nasu asiwò.
Standard catalog spine hardware si wodzrana ɖo le nudzraɖoƒe ƒe nutsyɔtsyɔ gã, kple le nudzraɖoƒe ƒe agbalẽɖoɖoɖa le dɔwɔŋkeke 3 me, trɔa akɔntabubua ŋutɔ — mèle lalam kwasiɖa geɖe be yeaɖo dometsotso aɖe me le wò nɔnɔmewo ƒe dometsotso me ne nya ŋutɔŋutɔ ƒe agbɔsɔsɔme dze vava gɔme o.
OEM ƒe kpekpeɖeŋu xɔa pitched loosely, eyata enyo be woama nusi te ŋu trɔna ŋutɔŋutɔ tso nusi bia mɔ̃ɖaŋununya ƒe kpeɖodzi ŋutɔŋutɔ gbɔ:
Adzɔnu ƒe dzeside ƒe tɔtrɔ — dzeside dzesi, laser etching, anodized amadede coding to didime — esia nye kabakaba eye mexɔ asi o, zi geɖe la, babla kple dzesi ƒe tɔtrɔ tsɔ wu atsyã ƒe tɔtrɔ
Packaging customization — tray ƒe ɖoɖo, label gbegbɔgblɔ, sterile mɔxenu packaging format — hã kabakaba vie be woawɔe
Nuŋlɔɖiwo ƒe kpekpeɖeŋu — ŋkɔ ŋɔŋlɔ ƒe faɛl dzadzraɖo, IFU gbegɔmeɖeɖe, mɔ̃ɖaŋu faɛl ƒe ɖoɖowɔwɔ na wò asi tɔxɛ ƒe ɖoɖowɔha — esia bia ɖoɖowɔwɔ ŋutɔŋutɔ gake mehiã be woatrɔ asi le nusi wotsɔ de eme ŋu o
Adzɔnuwo ƒe ɖoɖowɔwɔ le asi nu — tiatia si diameter ƒe didime, screw ƒomeviwo, kple atikplɔ ƒe didime ayi wò agbalẽdzraɖoƒe tɔxɛa me hena dukɔ aɖe koŋ ƒe amekola ƒe didiwo — esia nye nyametsotso tso afisi woakpɔe tsoe, ke menye atsyã ƒe tɔtrɔ o
Nusi to vovo — eye nusi wòle be woatsɔ aflaga aɖo edzi eme nakɔ, ke menye be woaɖee ɖa o — enye atsyã ƒe tɔtrɔ ŋutɔŋutɔ: screw ta ƒe geometry yeye, ka ƒe nɔnɔme si to vovo, atikplɔ ƒe didime si mele adzɔnuwɔƒea ƒe dometsotso si dzi woda asi ɖo fifia o. Ema bia be woalé ŋku ɖe aɖaŋu si wowɔ ŋu, woado mɔ̃wo kpɔ yeyee, eye woawɔ sedziwɔwɔ ŋuti nuŋlɔɖiwo yeyee. Enye subɔsubɔdɔ si le se nu si adzɔnuwɔƒe geɖe wɔna, gake ɣeyiɣi kple gazazã ŋutɔŋutɔ le esi, eye nudzrala ɖesiaɖe si agblɔ na wò be enye tɔtrɔ kabakaba le gavi ƒe nɔnɔme yeye aɖe ŋu la mele nu ƒom na wò tẽ o.
Enyo be woabu kpɔɖeŋu ʋɛ aɖewo be wonye nyametsotso ƒe teƒewo tsɔ wu be woabu wo be wonye masɔmasɔ suesuesuewo:
Woɖoa asixɔxɔ ŋuti nyatakaka ɖe wò hafi nèkpɔ nɔnɔmetata bliboa ƒe agbalẽvi si ƒo nu tso didime ƒe didime, didime ƒe didime, kple nusiwo woatsɔ awɔ dɔe ƒe tiatia ŋu
Woɖea nusiwo wowɔ ƒe foto siwo nye gaviwo ɖeɖeko fiana, eye womekpɔa nu le haƒonu siwo zɔna kpli wo me o
Womate ŋu agblɔe kɔte be titanium ƒe akɔbli ƒe dzidzenu si dzi nusiwo wotsɔ dea ame me ɖo la ɖo o, alo aɖo eŋu kple 'atikewɔwɔ ƒe dzeside titanium' si me mekɔ o.
Womate ŋu aɖe alesi set screw locking mechanism wɔa dɔ alo breakaway torque si wowɔe na la me o
Womateŋu awɔ batch traceability documentation ne wobia o, alo awɔ nu ɖe biabia la ŋu abe nusi mebɔ o ene o
Wogblɔa nudɔdɔ ƒe ŋugbedodowo ko be 'ɖoɖo kabakaba' eye womeɖe nusi tututu le nudzraɖoƒe me o ne wotsɔe sɔ kple esiwo wowɔ ɖe ɖoɖo nu
Wona pedicle screws le wo ɖokui si ko, kple akɔta ƒe ɖoɖo si keke wu o — si fia be interbody cage line aɖeke meli o, vidzidɔ ƒe tiatia aɖeke meli o, naneke meli si ana nàtu akɔta ƒe agbalẽdzraɖoƒe blibo kple nudzrala ɖeka ƒe ƒomedodo o
Esiawo dometɔ aɖeke ɖekaɖeka menaa nudzrala aɖeke medze o. Zi geɖe la, ne wotsɔ wo katã ƒo ƒui la, efia be èle nu wɔm kple asitsaha aɖe si gbugbɔa ame bubu ƒe adzɔnuwo dzrana, ke menye adzɔnuwɔƒe si kpɔa ŋusẽ ɖe ɖoɖoa dzi ŋutɔŋutɔ tso nuwuwu vaseɖe nuwuwu o.
Dzesidede Teƒe |
Nusiwo Woalé Kpɔ |
|---|---|
Nusiwo Wowɔ ƒe Agbɔsɔsɔme |
Ʋu gavi, MIS gavi, atikplɔ, crosslinks, kadodowo — blibo didime kple didime dometsotso |
Dɔwɔnuwo |
Dɔwɔnu siwo ɖea torque dzi kpɔtɔna, safui siwo seɖoƒe li na torque, tray siwo woɖo na dɔwɔwɔ siwo le ʋuʋu ɖi kple esiwo le MIS siaa |
Nu |
Titanium alloy grade si wogblɔ ɖe ASTM ƒe dzidzenu nu, mill ɖaseɖigbalẽwo li |
Nuŋlɔɖiwo |
ISO 13485 ƒe kekeme ƒe kpeɖeŋutɔ, CE nuŋlɔɖiwo, mɔ̃ɖaŋu kple ɖeɖiteameŋu dodokpɔ ŋuti nyatakakawo, batch traceability |
Vidzidzi |
Nudzraɖoƒe ŋutɔŋutɔ ƒe xɔxlɔ̃ le spec bliboa katã me, ɣeyiɣi ŋutɔŋutɔ le nudzraɖoƒe vs. lolome siwo wowɔ ɖe ɖoɖo nu |
OEM Kpekpeɖeŋunana |
Mamã si me kɔ le adzɔnu ƒe dzeside/nubablɛ ƒe tɔtrɔ kple atsyã ƒe tɔtrɔ vavãtɔ dome, kple ɣeyiɣiɖoɖo siwo sɔ na wo dometɔ ɖesiaɖe |
Ne èle China-si wotu ɖe adzɔnuwɔƒe aɖe dam ɖe Ɣetoɖoƒetɔwo ƒe adzɔnu aɖe dzi na pedicle screw systems koŋ la, ɖaseɖigbalẽ kple nyonyome ƒe susu ma ke si ŋu míeƒo nu tsoe le míaƒe tsɔtsɔ sɔ kple wo nɔewo si keke ta wu me China vs. United States ƒe akɔta wɔlawo wɔa dɔ le afisia — nusi tsoa nya me enye adzɔnuwo wɔwɔ ƒe amehehe si woŋlɔ ɖi, ke menye anyigbaŋutinunya o.
Ele be mamalawo nalé ŋku ɖe ɖoɖoa ƒe blibonyenye, gavi kple atikplɔ ƒe ɖekawɔwɔ, dɔwɔnu ƒe ɖoɖo ƒe ɖoɖowɔwɔ, ISO 13485 ƒe kekeme, nuwo ƒe kplɔkplɔ, mɔ̃ɖaŋu dodokpɔ nuŋlɔɖiwo, kple dɔdɔ ƒe kakaɖedzi ŋu hafi atsɔ unit ƒe asi asɔ kple wo nɔewo.
Ele be nudzrala si dze natsɔ ISO 13485 ƒe lolome ŋuti nyatakakawo, CE ƒe nuŋlɔɖiwo le afisi wòsɔ le, nusiwo wotsɔ wɔe ƒe ɖaseɖigbalẽwo, mɔ̃ɖaŋu kple ɖeɖiteameŋu dodokpɔ ŋuti nuŋlɔɖiwo, batch traceability, kple adzɔnuwo ƒe nɔnɔmewo hena mamalawo ƒe ŋkuléle ɖe wo ŋu.
Mamãla akpa gãtɔ hiã na aklã ƒe liƒolili le gaglãgbe kple MIS ƒe aklã ƒe ɖɔɖɔɖo ƒe tiatia siaa elabena kɔdzi ƒe nyawo ƒe tsakatsaka ate ŋu anye amekoko si wogbugbɔ trɔ asi le, ɖɔɖɔɖo si le ɖoƒe vovovowo, kple dɔléle siwo gblẽa nu le ŋutigbalẽ ŋu.
XC Medico ate ŋu ado alɔ OEM kple ame ŋutɔ ƒe ŋkɔ dede akɔta ƒe dɔwo kple adzɔnuwo ƒe ɖoɖowɔwɔ, babla, dzesidede, nuŋlɔɖiwo ƒe kpekpeɖeŋu, kple gɔmedzedze-afɔɖeɖe ƒe nudɔdɔ ƒe ɖoɖowɔwɔ tso 1 set MOQ.
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