Hyper-C

Screwdriver Self Retaining, Cervical

Registry build 21.09.26
53manufacturers in China registered for this device type
46catalogue 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 Hyper-C
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 2024-05-31 (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 Hyper-C
Catalogue number Size Status
02-02G In distribution
02-03P112 In distribution
02-04H In distribution
02-14P In distribution
02-03P114 In distribution
02-13G18 In distribution
02-03P214 In distribution
02-07G14 In distribution
02-13G10 In distribution
02-01G16 In distribution
02-05P In distribution
02-07G20 In distribution
02-07G10 In distribution
02-04P In distribution
02-27P In distribution
02-07G18 In distribution
02-18B In distribution
02-02P In distribution
02-04M In distribution
02-01G10 In distribution
02-01P10 In distribution
02-06G In distribution
02-14R In distribution
02-11G In distribution
02-01G20 In distribution
02-05H In distribution
02-03G In distribution
02-01P18 In distribution
02-07G16 In distribution
02-01P12 In distribution
02-07G12 In distribution
02-12G In distribution
02-13G16 In distribution
02-03P212 In distribution
02-13G12 In distribution
02-12P In distribution
02-01G14 In distribution
02-01P14 In distribution
02-01G12 In distribution
02-13G20 In distribution
02-08G In distribution
02-13G14 In distribution
02-04G In distribution
02-01G18 In distribution
02-37P In distribution
02-01P16 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