A.l.p.s. Mvx™

Mini Frag 2.0MM Screw Rack LID

Registry build 21.09.26
31manufacturers in China registered for this device type
425catalogue numbers in this listing
9510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWC
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11

Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone

Record

Regulatory record for A.l.p.s. mvX™
Listed by Tyber Medical, United States
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K242486
Record published 2023-12-15
Record revised 2025-08-15 (version 7)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for A.l.p.s. mvX™
Catalogue number Size Status
770241014 In distribution
770271046 In distribution
770271085 In distribution
770350032 In distribution
770150015 In distribution
770350042 In distribution
880352055S In distribution
770131014 In distribution
770240034 In distribution
770240042 In distribution
770241028 In distribution
770351048 In distribution
770241011 In distribution
770271028 In distribution
770400022 In distribution
770103050 In distribution
770240036 In distribution
770131006 In distribution
880401045S In distribution
770270036 In distribution
770200013 In distribution
770271080 In distribution
770300040 In distribution
770201011 In distribution
880401070S In distribution
770351075 In distribution
770300045 In distribution
770270018 In distribution
770151022 In distribution
770241015 In distribution
770151024 In distribution
770351095 In distribution
770201030 In distribution
770151007 In distribution
770200017 In distribution
770350090 In distribution
770270028 In distribution
770350085 In distribution
770271006 In distribution
770351010 In distribution
770241036 In distribution
770240065 In distribution
770241070 In distribution
770270010 In distribution
770150020 In distribution
770241055 In distribution
770400034 In distribution
770151012 In distribution
770240022 In distribution
770201019 In distribution
770351085 In distribution
770130006 In distribution
770240008 In distribution
770400042 In distribution
770201014 In distribution
770271008 In distribution
770200021 In distribution
770270015 In distribution
770240050 In distribution
770400065 In distribution
770240040 In distribution
770270095 In distribution
770270090 In distribution
770241042 In distribution
770200040 In distribution
770241048 In distribution
770400075 In distribution
770350024 In distribution
770350046 In distribution
770351020 In distribution
770270011 In distribution
770240075 In distribution
770400032 In distribution
770131011 In distribution
770241016 In distribution
770241032 In distribution
770271055 In distribution
770241008 In distribution
770351090 In distribution
770400050 In distribution
770130008 In distribution
770151015 In distribution
770130007 In distribution
770351026 In distribution
770350070 In distribution
770350095 In distribution
770350010 In distribution
770450050 In distribution
770400036 In distribution
770351012 In distribution
770350060 In distribution
770350012 In distribution
770271065 In distribution
770271022 In distribution
770150008 In distribution
770240017 In distribution
770241013 In distribution
770151017 In distribution
770201016 In distribution
770241046 In distribution
770270026 In distribution
770401050 In distribution
770150012 In distribution
770400016 In distribution
770271023 In distribution
770400055 In distribution
770351030 In distribution
770150007 In distribution
770400020 In distribution
770450060 In distribution
770350028 In distribution
770201038 In distribution
770131007 In distribution
770241024 In distribution
770200012 In distribution
770351018 In distribution
880300050S In distribution
880450045S In distribution
770151016 In distribution
770201034 In distribution
770351044 In distribution
770240012 In distribution
770401070 In distribution
770352040 In distribution
770401045 In distribution
770240013 In distribution
880300030S In distribution
880450040S In distribution
770201036 In distribution
770151006 In distribution
770401060 In distribution
770400100 In distribution
770200008 In distribution
770150018 In distribution
770241012 In distribution
770270013 In distribution
770350026 In distribution
770271030 In distribution
770271012 In distribution
770151023 In distribution
880300060S In distribution
770200030 In distribution
770270075 In distribution
770270085 In distribution
770351034 In distribution
770352055 In distribution
770352050 In distribution
770351016 In distribution
880352060S In distribution
770271048 In distribution
770351080 In distribution
770271013 In distribution
770201026 In distribution
770270006 In distribution
770350022 In distribution
770201022 In distribution
880401060S In distribution
770240018 In distribution
880300045S In distribution
880300055S In distribution
770350050 In distribution
770200024 In distribution
770240023 In distribution
770271026 In distribution
770300055 In distribution
770200016 In distribution
770240026 In distribution
770201021 In distribution
770241020 In distribution
770201018 In distribution
770271011 In distribution
770271010 In distribution
770270065 In distribution
770151021 In distribution
770200011 In distribution
770103090 In distribution
770350018 In distribution
770241009 In distribution
770201008 In distribution
770400014 In distribution
770270008 In distribution
770240055 In distribution
770400038 In distribution
770271021 In distribution
770401055 In distribution
770271100 In distribution
770240046 In distribution
770270046 In distribution
770400060 In distribution
770350075 In distribution
770150006 In distribution
770241050 In distribution
770270021 In distribution
770240007 In distribution
770240021 In distribution
770240060 In distribution
770350036 In distribution
770240044 In distribution
770150010 In distribution
770351022 In distribution
770350080 In distribution
770150022 In distribution
770271050 In distribution
880450050S In distribution
770241034 In distribution
770240006 In distribution
770241065 In distribution
770270016 In distribution
770271007 In distribution
770270044 In distribution
770270009 In distribution
770200023 In distribution
770150017 In distribution
770151011 In distribution
770200015 In distribution
770201009 In distribution
770150024 In distribution
770350044 In distribution
770150011 In distribution
770151019 In distribution
770270060 In distribution
770270024 In distribution
770130013 In distribution
770200014 In distribution
770271032 In distribution
770400026 In distribution
770271018 In distribution
770300060 In distribution
880352050S In distribution
770240070 In distribution
770130012 In distribution
880450055S In distribution
770271014 In distribution
770351060 In distribution
770201017 In distribution
770241021 In distribution
770107020 In distribution
770351065 In distribution
770270048 In distribution
770271019 In distribution
770271044 In distribution
770201015 In distribution
770241030 In distribution
770201028 In distribution
770270100 In distribution
770351042 In distribution
770200007 In distribution
770240038 In distribution
770103010 In distribution
770400048 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Screw, Fixation, Bone Synthes Gmbh 3,975
Aptus Medartis Inc. 3,623
Acumed Acumed LLC 3,187
Arthrex® Arthrex, Inc. 2,781
OsteoMed Osteomed 2,764
Screw, Fixation, Bone AAP Implantate AG 2,176
Screw, Fixation, Bone Zimmer, Inc. 1,993
Arix System Bone Screw Jeil Medical Corporation 1,875
Cannulated Screw System + Tyber Medical 1,814
Cannulated Compression Headless Screw Tyber Medical 1,621
Microware Bone Plates and Bone Screws Microware Precision Co., Ltd. 1,601
Anthem Globus Medical, Inc. 1,538

Showing 12 of 5,775. All products under Screw, Fixation, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K253042 2026-04-03
K252901 2025-12-31
K192975 2020-01-09
K192974 2020-01-08
K170571 2017-06-20
K161597 2016-11-16
K153575 2016-02-26
K153180 2015-11-25
K133842 2014-03-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer