LCP
Pediatric LCP(TM) HIP Plate 3.5MM 110°-STERILE
3manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | JDS |
| Device type | Nail, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K062872 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 10) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02.108.323 | In distribution | |
| 02.108.321 | In distribution | |
| 02.108.326 | In distribution | |
| 02.108.320 | In distribution | |
| 02.108.315 | In distribution | |
| 02.108.342 | In distribution | |
| 02.108.311S | In distribution | |
| 02.108.301 | In distribution | |
| 02.108.331 | In distribution | |
| 02.108.332 | In distribution | |
| 02.108.313S | In distribution | |
| 02.108.330 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Autobahn | Globus Medical, Inc. | 1,102 |
| Trigen | Smith & Nephew, Inc. | 1,062 |
| Nail, Fixation, Bone | Synthes Gmbh | 296 |
| Nail, Fixation, Bone | Synthes (U.S.A.) LP | 237 |
| Intertan MAX | Smith & Nephew, Inc. | 235 |
| EXPert Nail | Synthes Gmbh | 225 |
| Trigen MAX | Smith & Nephew, Inc. | 172 |
| Ajax Nail | Auxein medical Private limited | 168 |
| GPC | GPC Medical Limited | 155 |
| 130° Ga-mma Nail | Auxein medical Private limited | 90 |
| Ender Nail | Smith & Nephew, Inc. | 82 |
| Centronail Titanium Humeral Nailing System | Orthofix SRL | 79 |
Showing 12 of 112. All products under Nail, Fixation, Bone
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-06-03 | Class II | Employee error | A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection. | 3 | 2015-09-15 |
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.