LCP

OI LCP Volr Clmn Dstl Radius PL 6H HEAD/4H Shaft/RT-Sterile

Registry build 21.09.26
22manufacturers in China registered for this device type
62catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRS
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Kingj Medical Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7
Hangzhou Sino-MIM Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 6
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Beijing AK Medical Co., Ltd. Changping District Beijing Contract manufacturer 3

Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone

Record

Regulatory record for LCP
Listed by Synthes (U.S.A.) LP
FDA product code HRS
Device type Plate, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3030
510(k) K013248
Record published 2015-09-14
Record revised 2026-06-30 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Distribution end date 2026-06-30

Catalogue Numbers

Catalogue numbers for LCP
Catalogue number Size Status
239.917S Withdrawn
239.913 Withdrawn
239.920S Withdrawn
239.912 Withdrawn
04.110.730 Withdrawn
239.912S Withdrawn
04.110.440 Withdrawn
239.904S Withdrawn
238.705S Withdrawn
239.908 Withdrawn
238.705 Withdrawn
238.703 Withdrawn
239.901S Withdrawn
04.110.331 Withdrawn
238.702S Withdrawn
238.707S Withdrawn
239.909S Withdrawn
238.702 Withdrawn
238.706S Withdrawn
04.110.441 Withdrawn
239.908S Withdrawn
04.110.731 Withdrawn
238.710S Withdrawn
239.916 Withdrawn
239.921S Withdrawn
04.110.740S Withdrawn
239.913S Withdrawn
238.703S Withdrawn
239.916S Withdrawn
04.110.751 Withdrawn
238.711S Withdrawn
239.917 Withdrawn
238.708 Withdrawn
04.110.340 Withdrawn
238.708S Withdrawn
239.901 Withdrawn
239.900S Withdrawn
239.904 Withdrawn
238.706 Withdrawn
238.700S Withdrawn
239.905 Withdrawn
04.110.451 Withdrawn
239.921 Withdrawn
238.709 Withdrawn
238.701 Withdrawn
238.701S Withdrawn
04.110.430 Withdrawn
04.110.750 Withdrawn
238.704S Withdrawn
238.707 Withdrawn
238.704 Withdrawn
238.709S Withdrawn
04.110.731S Withdrawn
04.110.741 Withdrawn
04.110.341 Withdrawn
238.700 Withdrawn
04.110.840 Withdrawn
239.909 Withdrawn
238.711 Withdrawn
239.905S Withdrawn
04.110.450 Withdrawn
238.710 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Pectus System Biomet Microfixation 4,662
Arthrex® Arthrex, Inc. 3,031
Evos Smith & Nephew, Inc. 2,235
Peri-Loc Smith & Nephew, Inc. 2,196
OsteoMed Osteomed 1,961
VariAx Stryker GmbH 1,934
Aptus Medartis Inc. 1,688
TC-100 Smith & Nephew, Inc. 1,639
Plate, Fixation, Bone Synthes Gmbh 1,613
Anthem Globus Medical, Inc. 1,551
Acumed Acumed LLC 1,360
Signex Osteonic Co., Ltd. 1,310

Showing 12 of 3,530. All products under Plate, Fixation, Bone

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