EXPert Nail
TI END CAP T25 Strdrv 15MM EXT Ster/Humeral Nail-EX Sprl BLD
3manufacturers in China registered for this device type
225catalogue 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) | K040762 |
| Record published | 2015-09-14 |
| Record revised | 2026-02-09 (version 7) |
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 |
|---|---|---|
| 04.004.664S | In distribution | |
| 04.004.001S | In distribution | |
| 04.034.337S | In distribution | |
| 04.001.244S | In distribution | |
| 04.001.422S | In distribution | |
| 04.034.661S | In distribution | |
| 04.004.361S | In distribution | |
| 04.004.440S | In distribution | |
| 04.004.255S | In distribution | |
| 04.001.003S | In distribution | |
| 04.004.008S | In distribution | |
| 04.034.267S | In distribution | |
| 04.034.640S | In distribution | |
| 04.004.003 | In distribution | |
| 04.004.246S | In distribution | |
| 04.034.343S | In distribution | |
| 04.034.731S | In distribution | |
| 04.004.446S | In distribution | |
| 04.004.540S | In distribution | |
| 04.001.628S | In distribution | |
| 04.034.537S | In distribution | |
| 04.001.001 | In distribution | |
| 04.004.634S | In distribution | |
| 04.004.452S | In distribution | |
| 04.004.661S | In distribution | |
| 04.004.267S | In distribution | |
| 04.034.449S | In distribution | |
| 04.001.242S | In distribution | |
| 04.001.236S | In distribution | |
| 04.004.564S | In distribution | |
| 04.001.218S | In distribution | |
| 04.034.646S | In distribution | |
| 04.001.222S | In distribution | |
| 04.001.624S | In distribution | |
| 04.034.637S | In distribution | |
| 04.001.432S | In distribution | |
| 04.004.740S | In distribution | |
| 04.004.437S | In distribution | |
| 04.004.734S | In distribution | |
| 04.034.434S | In distribution | |
| 04.004.743S | In distribution | |
| 04.004.346S | In distribution | |
| 04.004.755S | In distribution | |
| 04.034.367S | In distribution | |
| 04.004.258S | In distribution | |
| 04.004.567S | In distribution | |
| 04.004.352S | In distribution | |
| 04.004.000 | In distribution | |
| 04.004.761S | In distribution | |
| 04.034.664S | In distribution | |
| 04.001.442S | In distribution | |
| 04.034.737S | In distribution | |
| 04.004.252S | In distribution | |
| 04.034.555S | In distribution | |
| 04.001.420S | In distribution | |
| 04.001.232S | In distribution | |
| 04.004.008 | In distribution | |
| 04.034.746S | In distribution | |
| 04.034.261S | In distribution | |
| 04.004.431S | In distribution | |
| 04.001.438S | In distribution | |
| 04.001.620S | In distribution | |
| 04.001.430S | In distribution | |
| 04.001.230S | In distribution | |
| 04.004.643S | In distribution | |
| 04.034.564S | In distribution | |
| 04.001.634S | In distribution | |
| 04.034.740S | In distribution | |
| 04.004.009S | In distribution | |
| 04.034.246S | In distribution | |
| 04.034.446S | In distribution | |
| 04.001.410S | In distribution | |
| 04.004.658S | In distribution | |
| 04.034.658S | In distribution | |
| 04.004.561S | In distribution | |
| 04.004.531S | In distribution | |
| 04.001.610S | In distribution | |
| 04.004.231S | In distribution | |
| 04.034.631S | In distribution | |
| 04.001.436S | In distribution | |
| 04.004.546S | In distribution | |
| 04.034.364S | In distribution | |
| 04.034.346S | In distribution | |
| 04.004.543S | In distribution | |
| 04.004.752S | In distribution | |
| 04.004.434S | In distribution | |
| 04.004.746S | In distribution | |
| 04.004.537S | In distribution | |
| 04.001.220S | In distribution | |
| 04.034.667S | In distribution | |
| 04.001.622S | In distribution | |
| 04.034.461S | In distribution | |
| 04.001.428S | In distribution | |
| 04.004.367S | In distribution | |
| 04.004.249S | In distribution | |
| 04.034.431S | In distribution | |
| 04.001.234S | In distribution | |
| 04.034.549S | In distribution | |
| 04.001.210S | In distribution | |
| 04.004.637S | In distribution | |
| 04.034.443S | In distribution | |
| 04.004.767S | In distribution | |
| 04.004.749S | In distribution | |
| 04.004.764S | In distribution | |
| 04.034.655S | In distribution | |
| 04.004.731S | In distribution | |
| 04.034.464S | In distribution | |
| 04.034.252S | In distribution | |
| 04.001.626S | In distribution | |
| 04.004.646S | In distribution | |
| 04.034.761S | In distribution | |
| 04.004.458S | In distribution | |
| 04.001.240S | In distribution | |
| 04.004.443S | In distribution | |
| 04.001.440S | In distribution | |
| 04.034.764S | In distribution | |
| 04.034.634S | In distribution | |
| 04.034.567S | In distribution | |
| 04.004.534S | In distribution | |
| 04.034.340S | In distribution | |
| 04.034.649S | In distribution | |
| 04.034.231S | In distribution | |
| 04.004.011S | In distribution | |
| 04.001.424S | In distribution | |
| 04.001.644S | In distribution | |
| 04.034.352S | In distribution | |
| 04.004.002S | In distribution | |
| 04.034.255S | In distribution | |
| 04.034.543S | In distribution | |
| 04.004.649S | In distribution | |
| 04.004.011 | In distribution | |
| 04.034.358S | In distribution | |
| 04.034.561S | In distribution | |
| 04.001.226S | In distribution | |
| 04.004.349S | In distribution | |
| 04.034.531S | In distribution | |
| 04.004.631S | In distribution | |
| 04.001.618S | In distribution | |
| 04.001.638S | In distribution | |
| 04.034.534S | In distribution | |
| 04.004.737S | In distribution | |
| 04.034.458S | In distribution | |
| 04.034.652S | In distribution | |
| 04.001.418S | In distribution | |
| 04.034.249S | In distribution | |
| 04.001.001S | In distribution | |
| 04.004.464S | In distribution | |
| 04.004.331S | In distribution | |
| 04.001.642S | In distribution | |
| 04.004.240S | In distribution | |
| 04.001.224S | In distribution | |
| 04.004.261S | In distribution | |
| 04.034.240S | In distribution | |
| 04.034.643S | In distribution | |
| 04.001.002 | In distribution | |
| 04.004.655S | In distribution | |
| 04.004.003S | In distribution | |
| 04.004.010S | In distribution | |
| 04.001.630S | In distribution | |
| 04.034.361S | In distribution | |
| 04.001.640S | In distribution | |
| 04.034.452S | In distribution | |
| 04.004.355S | In distribution | |
| 04.034.264S | In distribution | |
| 04.001.000 | In distribution | |
| 04.004.640S | In distribution | |
| 04.004.558S | In distribution | |
| 04.004.555S | In distribution | |
| 04.034.437S | In distribution | |
| 04.001.000S | In distribution | |
| 04.004.234S | In distribution | |
| 04.034.355S | In distribution | |
| 04.034.734S | In distribution | |
| 04.001.632S | In distribution | |
| 04.034.258S | In distribution | |
| 04.004.000S | In distribution | |
| 04.034.440S | In distribution | |
| 04.004.461S | In distribution | |
| 04.004.340S | In distribution | |
| 04.004.001 | In distribution | |
| 04.004.467S | In distribution | |
| 04.034.234S | In distribution | |
| 04.004.758S | In distribution | |
| 04.004.002 | In distribution | |
| 04.004.455S | In distribution | |
| 04.034.237S | In distribution | |
| 04.034.467S | In distribution | |
| 04.034.743S | In distribution | |
| 04.034.558S | In distribution | |
| 04.034.546S | In distribution | |
| 04.034.767S | In distribution | |
| 04.004.652S | In distribution | |
| 04.004.343S | In distribution | |
| 04.004.009 | In distribution | |
| 04.001.444S | In distribution | |
| 04.001.228S | In distribution | |
| 04.034.752S | In distribution | |
| 04.034.749S | In distribution | |
| 04.034.552S | In distribution | |
| 04.004.667S | In distribution | |
| 04.034.540S | In distribution | |
| 04.034.243S | In distribution | |
| 04.004.549S | In distribution | |
| 04.001.003 | In distribution | |
| 04.004.264S | In distribution | |
| 04.001.238S | In distribution | |
| 04.004.552S | In distribution | |
| 04.004.243S | In distribution | |
| 04.034.331S | In distribution | |
| 04.001.636S | In distribution | |
| 04.001.434S | In distribution | |
| 04.034.349S | In distribution | |
| 04.034.334S | In distribution | |
| 04.004.449S | In distribution | |
| 04.034.758S | In distribution | |
| 04.001.426S | In distribution | |
| 04.004.010 | In distribution | |
| 04.034.755S | In distribution | |
| 04.004.237S | In distribution | |
| 04.034.455S | In distribution | |
| 04.004.337S | In distribution | |
| 04.004.358S | In distribution | |
| 04.004.364S | In distribution | |
| 04.004.334S | In distribution | |
| 04.001.002S | 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 |
| 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 |
| Expert Femoral Nail | Auxein medical Private limited | 70 |
Showing 12 of 112. All products under Nail, Fixation, Bone
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes Gmbh | 510(k) number | 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 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-30 | Class II | Pending | The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. | 14 | 2015-09-10 |
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.