F1 MPS

Screw Driver, Adjuster, T25, Joust

Registry build 21.09.26
53manufacturers in China registered for this device type
83catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for F1 MPS
Listed by Degen Medical, United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-08-22
Record revised 2022-12-08 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for F1 MPS
Catalogue number Size Status
01-0095G2 In distribution
01-0075G2 In distribution
01-0013P0 In distribution
01-30R In distribution
01-25H In distribution
01-28P In distribution
01-0004P1 In distribution
01-01P In distribution
01-0003P0 In distribution
01-02S In distribution
01-0006H0 In distribution
01-03P In distribution
01-0008P0 In distribution
01-0005E0 In distribution
01-0002H0 In distribution
01-0012P0 In distribution
01-0065G2 In distribution
01-0009P0 In distribution
01-36S-002 In distribution
01-0045G1 In distribution
01-49E In distribution
01-0085G2 In distribution
01-22B In distribution
01-0065G1 In distribution
01-0001M0 In distribution
01-50M In distribution
01-01G0-18 In distribution
01-0001S0 In distribution
01-01G0-22 In distribution
01-0009E0 In distribution
01-05P In distribution
01-0002P0 In distribution
01-0055G3 In distribution
01-0001H0 In distribution
01-38H In distribution
01-0011P0 In distribution
01-0005P0 In distribution
01-0003E0 In distribution
01-34E In distribution
01-07P In distribution
01-52P In distribution
01-09P In distribution
01-01G2-18 In distribution
01-0085G1 In distribution
01-32P In distribution
01-0002M0 In distribution
01-01S In distribution
01-0002S0 In distribution
01-0075G1 In distribution
01-0001E0 In distribution
01-01E In distribution
01-0004E0 In distribution
01-0095G1 In distribution
01-10P In distribution
01-0010P0 In distribution
01-01G1-22 In distribution
01-01G1-18 In distribution
01-0003H0 In distribution
01-01G2-22 In distribution
01-08P In distribution
01-01D In distribution
01-0045G2 In distribution
01-0075G3 In distribution
01-0015P0 In distribution
01-0045G3 In distribution
01-0007P0 In distribution
01-0065G3 In distribution
01-0006E0 In distribution
01-06P In distribution
01-0055G2 In distribution
01-0055G1 In distribution
01-23M In distribution
01-0002E0 In distribution
01-31R In distribution
01-0004P0 In distribution
01-14G In distribution
01-02M In distribution
01-11P In distribution
01-0001R0 In distribution
01-0007H0 In distribution
01-02E In distribution
01-36S-001 In distribution
01-0006P0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument

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