Kmedic

Handle Quick Coupling FOR Small Instruments 4 1/2

Registry build 21.09.26
53manufacturers in China registered for this device type
21catalogue 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 Kmedic
Listed by Teleflex Medical 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, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-09-15
Record revised 2026-02-05 (version 13)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Sizes Length 2.5 to 30 cm; length 4 to 12 in; outer diameter 1 in
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Kmedic
Catalogue number Size Status
IPN015137 Length 14 cm In distribution
IPN014373 Length 3.2 cm In distribution
IPN014882 Length 18.4 cm In distribution
IPN015169 Length 19 cm In distribution
IPN013867 Length 12 in In distribution
IPN013870 Outer Diameter 1 in In distribution
IPN013998 Length 20.3 cm In distribution
IPN015170 Length 19.1 cm In distribution
IPN015171 Length 19 cm In distribution
IPN014371 Length 2.5 cm In distribution
IPN014315 Length 12.7 cm In distribution
IPN014372 Length 2.5 cm In distribution
IPN014317 Length 30 cm In distribution
IPN013866 Length 12 in In distribution
IPN014316 Length 11.6 cm In distribution
IPN013869 Length 4 in In distribution
IPN014313 Length 12.7 cm In distribution
IPN015172 Length 19.1 cm In distribution
IPN014314 Length 4.125 cm In distribution
IPN013994 flexible shaft In distribution
IPN015118 Length 12 cm 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