Viper

Viper 2 System Multi-Piece Screw Extension Castle NUT Remover

Registry build 21.09.26
53manufacturers in China registered for this device type
41catalogue 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 Viper
Listed by Depuy Spine, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-11-08
Record revised 2026-04-03 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2024-06-14

Catalogue Numbers

Catalogue numbers for Viper
Catalogue number Size Status
286715111 In distribution
286730160 In distribution
286720200 In distribution
286720360 In distribution
286705200 In distribution
286725350 In distribution
286725405 In distribution
286715300 In distribution
286710400 In distribution
286725300 In distribution
286725050 In distribution
286735300 In distribution
286705220 In distribution
286735735 In distribution
286735200 In distribution
286735730 In distribution
286715100 In distribution
286715350 In distribution
286735750 In distribution
286705350 In distribution
286717011 In distribution
286710490 In distribution
286760217 In distribution
286745500 In distribution
286735725 In distribution
286705210 In distribution
286725200 In distribution
286760210 In distribution
286735110 In distribution
286738000 In distribution
286738010 In distribution
279734200 In distribution
286705790 In distribution
286725225 In distribution
286710100 In distribution
286720310 In distribution
286705230 In distribution
286735100 In distribution
286725226 In distribution
286765125 In distribution
286760550 Withdrawn

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