Nail, Fixation, Bone
TI END CAP 10MM EXT-Sterile FOR Humeral Nail Spiral Blade
3manufacturers in China registered for this device type
237catalogue numbers in this listing
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 (U.S.A.) LP |
|---|---|
| FDA product code | JDS |
| Device type | Nail, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K914371 |
| Record published | 2015-09-14 |
| Record revised | 2026-06-30 (version 9) |
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 number | Size | Status |
|---|---|---|
| 274.92S | Withdrawn | |
| 274.69S | Withdrawn | |
| 274.59 | Withdrawn | |
| 274.86 | Withdrawn | |
| 274.71S | Withdrawn | |
| 274.16S | Withdrawn | |
| 485.327S | Withdrawn | |
| 274.40S | Withdrawn | |
| 462.666S | Withdrawn | |
| 458.822 | Withdrawn | |
| 459.95 | Withdrawn | |
| 274.42 | Withdrawn | |
| 274.80S | Withdrawn | |
| 458.878 | Withdrawn | |
| 274.38 | Withdrawn | |
| 458.846S | Withdrawn | |
| 274.60S | Withdrawn | |
| 274.30S | Withdrawn | |
| 458.828 | Withdrawn | |
| 274.28S | Withdrawn | |
| 458.110S | Withdrawn | |
| 458.848S | Withdrawn | |
| 274.09S | Withdrawn | |
| 274.20 | Withdrawn | |
| 274.61 | Withdrawn | |
| 458.78S | Withdrawn | |
| 274.43 | Withdrawn | |
| 274.87S | Withdrawn | |
| 274.42S | Withdrawn | |
| 274.83S | Withdrawn | |
| 274.29S | Withdrawn | |
| 274.57S | Withdrawn | |
| 458.70 | Withdrawn | |
| 274.43S | Withdrawn | |
| 274.88 | Withdrawn | |
| 458.844 | Withdrawn | |
| 274.10S | Withdrawn | |
| 274.17S | Withdrawn | |
| 458.80S | Withdrawn | |
| 458.76 | Withdrawn | |
| 458.66S | Withdrawn | |
| 258.58 | Withdrawn | |
| 274.75 | Withdrawn | |
| 258.30 | Withdrawn | |
| 274.33S | Withdrawn | |
| 462.660S | Withdrawn | |
| 274.58S | Withdrawn | |
| 274.14 | Withdrawn | |
| 458.70S | Withdrawn | |
| 274.04S | Withdrawn | |
| 458.864 | Withdrawn | |
| 274.41 | Withdrawn | |
| 458.858 | Withdrawn | |
| 458.840S | Withdrawn | |
| 458.878S | Withdrawn | |
| 274.02S | Withdrawn | |
| 274.89 | Withdrawn | |
| 274.65S | Withdrawn | |
| 274.77S | Withdrawn | |
| 458.110 | Withdrawn | |
| 485.336S | Withdrawn | |
| 259.48 | Withdrawn | |
| 458.66 | Withdrawn | |
| 274.44 | Withdrawn | |
| 274.36S | Withdrawn | |
| 274.95S | Withdrawn | |
| 274.79S | Withdrawn | |
| 274.52S | Withdrawn | |
| 458.72S | Withdrawn | |
| 274.06S | Withdrawn | |
| 274.61S | Withdrawn | |
| 274.36 | Withdrawn | |
| 274.64 | Withdrawn | |
| 274.54 | Withdrawn | |
| 274.51S | Withdrawn | |
| 458.824S | Withdrawn | |
| 259.100 | Withdrawn | |
| 274.55S | Withdrawn | |
| 258.32 | Withdrawn | |
| 274.26S | Withdrawn | |
| 274.93S | Withdrawn | |
| 274.27 | Withdrawn | |
| 274.86S | Withdrawn | |
| 274.87 | Withdrawn | |
| 258.64 | Withdrawn | |
| 274.39 | Withdrawn | |
| 258.60 | Withdrawn | |
| 274.13S | Withdrawn | |
| 458.68S | Withdrawn | |
| 458.840 | Withdrawn | |
| 458.830S | Withdrawn | |
| 458.824 | Withdrawn | |
| 274.50 | Withdrawn | |
| 274.34S | Withdrawn | |
| 462.666 | Withdrawn | |
| 274.41S | Withdrawn | |
| 459.34 | Withdrawn | |
| 258.40 | Withdrawn | |
| 259.68 | Withdrawn | |
| 274.53 | Withdrawn | |
| 274.16 | Withdrawn | |
| 459.85 | Withdrawn | |
| 258.62 | Withdrawn | |
| 274.31 | Withdrawn | |
| 462.667S | Withdrawn | |
| 458.852S | Withdrawn | |
| 274.19 | Withdrawn | |
| 274.03S | Withdrawn | |
| 274.94S | Withdrawn | |
| 274.51 | Withdrawn | |
| 274.19S | Withdrawn | |
| 274.73 | Withdrawn | |
| 274.46S | Withdrawn | |
| 274.65 | Withdrawn | |
| 274.38S | Withdrawn | |
| 274.66S | Withdrawn | |
| 274.23S | Withdrawn | |
| 274.35S | Withdrawn | |
| 274.39S | Withdrawn | |
| 459.68 | Withdrawn | |
| 274.81S | Withdrawn | |
| 462.722 | Withdrawn | |
| 259.72 | Withdrawn | |
| 274.72S | Withdrawn | |
| 274.01S | Withdrawn | |
| 259.54 | Withdrawn | |
| 274.21S | Withdrawn | |
| 458.830 | Withdrawn | |
| 458.834 | Withdrawn | |
| 274.15S | Withdrawn | |
| 274.60 | Withdrawn | |
| 458.822S | Withdrawn | |
| 274.26 | Withdrawn | |
| 274.07S | Withdrawn | |
| 274.74S | Withdrawn | |
| 274.78 | Withdrawn | |
| 274.73S | Withdrawn | |
| 274.82S | Withdrawn | |
| 274.11S | Withdrawn | |
| 274.56 | Withdrawn | |
| 274.14S | Withdrawn | |
| 274.49S | Withdrawn | |
| 458.864S | Withdrawn | |
| 274.47 | Withdrawn | |
| 459.40S | Withdrawn | |
| 274.00S | Withdrawn | |
| 458.856S | Withdrawn | |
| 274.11 | Withdrawn | |
| 274.55 | Withdrawn | |
| 274.68S | Withdrawn | |
| 274.53S | Withdrawn | |
| 274.78S | Withdrawn | |
| 274.50S | Withdrawn | |
| 274.18S | Withdrawn | |
| 259.90 | Withdrawn | |
| 458.820S | Withdrawn | |
| 274.20S | Withdrawn | |
| 258.28 | Withdrawn | |
| 458.836 | Withdrawn | |
| 458.76S | Withdrawn | |
| 458.850S | Withdrawn | |
| 458.818 | Withdrawn | |
| 258.46 | Withdrawn | |
| 274.85S | Withdrawn | |
| 274.25 | Withdrawn | |
| 258.36 | Withdrawn | |
| 458.880 | Withdrawn | |
| 274.76S | Withdrawn | |
| 274.63S | Withdrawn | |
| 462.665 | Withdrawn | |
| 458.72 | Withdrawn | |
| 274.84 | Withdrawn | |
| 274.08S | Withdrawn | |
| 462.667 | Withdrawn | |
| 274.27S | Withdrawn | |
| 258.38 | Withdrawn | |
| 458.858S | Withdrawn | |
| 462.723 | Withdrawn | |
| 458.880S | Withdrawn | |
| 274.18 | Withdrawn | |
| 274.62S | Withdrawn | |
| 274.70S | Withdrawn | |
| 458.874S | Withdrawn | |
| 274.06 | Withdrawn | |
| 274.64S | Withdrawn | |
| 274.45S | Withdrawn | |
| 458.74 | Withdrawn | |
| 274.75S | Withdrawn | |
| 459.42 | Withdrawn | |
| 274.29 | Withdrawn | |
| 274.66 | Withdrawn | |
| 274.56S | Withdrawn | |
| 274.47S | Withdrawn | |
| 274.89S | Withdrawn | |
| 274.67S | Withdrawn | |
| 462.660 | Withdrawn | |
| 274.37S | Withdrawn | |
| 458.828S | Withdrawn | |
| 274.82 | Withdrawn | |
| 274.12S | Withdrawn | |
| 274.17 | Withdrawn | |
| 274.54S | Withdrawn | |
| 274.58 | Withdrawn | |
| 274.15 | Withdrawn | |
| 274.05S | Withdrawn | |
| 274.88S | Withdrawn | |
| 458.850 | Withdrawn | |
| 458.848 | Withdrawn | |
| 274.52 | Withdrawn | |
| 459.72 | Withdrawn | |
| 458.846 | Withdrawn | |
| 274.84S | Withdrawn | |
| 274.44S | Withdrawn | |
| 274.24 | Withdrawn | |
| 274.32S | Withdrawn | |
| 459.48S | Withdrawn | |
| 274.48S | Withdrawn | |
| 458.820 | Withdrawn | |
| 274.31S | Withdrawn | |
| 259.60 | Withdrawn | |
| 274.63 | Withdrawn | |
| 458.826 | Withdrawn | |
| 274.96S | Withdrawn | |
| 274.25S | Withdrawn | |
| 274.24S | Withdrawn | |
| 274.05 | Withdrawn | |
| 274.85 | Withdrawn | |
| 274.92 | Withdrawn | |
| 458.74S | Withdrawn | |
| 274.97S | Withdrawn | |
| 274.22S | Withdrawn | |
| 274.40 | Withdrawn | |
| 274.62 | Withdrawn | |
| 274.74 | Withdrawn | |
| 274.30 | Withdrawn | |
| 274.59S | Withdrawn | |
| 258.26 | Withdrawn |
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 |
| 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 |
| Expert Femoral Nail | Auxein medical Private limited | 70 |
Showing 12 of 112. All products under Nail, Fixation, Bone
Recalls Naming This Product
4 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 | 2013-04-18 | Class II | Packaging process control | Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. | 1 | 2015-03-30 |
| Synthes USA (HQ), Inc. | 510(k) number | 2010-02-25 | Not classified | Device Design | potential compatibility issue | 1 unit | 2014-10-20 |
| Synthes USA (HQ), Inc. | 510(k) number | 2010-02-25 | Not classified | Device Design | potential compatibility issue | 5 units | 2014-10-20 |
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.