Key Surgical K-Wire and Pin Covers

K-Wire Covers, Sterile, Yellow, .028-inch inner diameter, 0.7mm, 2 per package

Registry build 21.09.26
53manufacturers in China registered for this device type
24catalogue 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 Key Surgical K-Wire and Pin Covers
Listed by Key Surgical, LLC, 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 2020-12-09
Record revised 2025-03-17 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Box of 12
Sizes Lumen/inner diameter 0.028 to 0.177 in
Distribution end date 2025-08-26

Catalogue Numbers

Catalogue numbers for Key Surgical K-Wire and Pin Covers
Catalogue number Size Per pack Status
C-078 Lumen/Inner Diameter.078 in 2 Withdrawn
C-035NS Lumen/Inner Diameter.035 in 50 Withdrawn
C-093NS Lumen/Inner Diameter.093 in 50 Withdrawn
C-109NS Lumen/Inner Diameter.109 in 50 Withdrawn
C-028 Lumen/Inner Diameter.028 in Withdrawn
C-093 Lumen/Inner Diameter.093 in 2 Withdrawn
C-109 Lumen/Inner Diameter.109 in 2 Withdrawn
C-078NS Lumen/Inner Diameter.078 in 50 Withdrawn
C-035 Lumen/Inner Diameter.035 in 2 Withdrawn
C-045 Lumen/Inner Diameter 0.043 in 2 Withdrawn
C-125NS Lumen/Inner Diameter.125 in 50 Withdrawn
C-141NS Lumen/Inner Diameter 0.137 in 50 Withdrawn
C-188 Lumen/Inner Diameter 0.177 in 2 Withdrawn
C-125 Lumen/Inner Diameter.125 in 2 Withdrawn
C-188NS Lumen/Inner Diameter 0.177 in 50 Withdrawn
C-045NS Lumen/Inner Diameter 0.043 in 50 Withdrawn
C-156NS Lumen/Inner Diameter.156 in 50 Withdrawn
C-141 Lumen/Inner Diameter 0.137 in 2 Withdrawn
C-156 Lumen/Inner Diameter.156 in 2 Withdrawn
C-054 Lumen/Inner Diameter.054 in 2 Withdrawn
C-062NS Lumen/Inner Diameter.062 in 50 Withdrawn
C-028NS Lumen/Inner Diameter.028 in Withdrawn
C-054NS Lumen/Inner Diameter.054 in 50 Withdrawn
C-062 Lumen/Inner Diameter.062 in 2 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