130° Ga-Mma Nail
130° Ga-mma Nail Type-II, Long, Right, Ø11mm x Length 380mm, Titanium
3manufacturers in China registered for this device type
90catalogue numbers in this listing
1510(k) clearance
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 | Auxein medical Private limited, India |
|---|---|
| FDA product code | JDS |
| Device type | Nail, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K192003 |
| Record published | 2020-10-23 |
| Record revised | 2025-02-06 (version 3) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TI-1457L-10-380L | In distribution | |
| TI-1457L-12-320L | In distribution | |
| TI-1457S-10-240 | In distribution | |
| TI-1457L-11-380R | In distribution | |
| TI-1457L-13-360L | In distribution | |
| TI-1457L-13-420R | In distribution | |
| TI-1457L-13-380R | In distribution | |
| TI-1457L-13-360R | In distribution | |
| TI-1457L-12-400R | In distribution | |
| TI-1457L-12-340L | In distribution | |
| TI-1457L-12-440L | In distribution | |
| TI-1457L-13-320R | In distribution | |
| TI-1457S-13-200 | In distribution | |
| TI-1457S-11-200 | In distribution | |
| TI-1457L-10-400R | In distribution | |
| TI-1457L-09-320R | In distribution | |
| TI-1457L-12-360L | In distribution | |
| TI-1457L-11-440L | In distribution | |
| TI-1457S-09-180 | In distribution | |
| TI-1457L-12-380L | In distribution | |
| TI-1457S-11-180 | In distribution | |
| TI-1457L-10-400L | In distribution | |
| TI-1457L-11-360R | In distribution | |
| TI-1457L-10-360R | In distribution | |
| TI-1457L-09-380L | In distribution | |
| TI-1457L-13-440R | In distribution | |
| TI-1457L-11-380L | In distribution | |
| TI-1457L-12-400L | In distribution | |
| TI-1457S-12-200 | In distribution | |
| TI-1457L-09-380R | In distribution | |
| TI-1457L-12-440R | In distribution | |
| TI-1457L-09-340R | In distribution | |
| TI-1457L-11-320L | In distribution | |
| TI-1457L-09-340L | In distribution | |
| TI-1457L-12-340R | In distribution | |
| TI-1457L-09-400R | In distribution | |
| TI-1457S-12-240 | In distribution | |
| TI-1457L-12-420R | In distribution | |
| TI-1457L-12-320R | In distribution | |
| TI-1457L-13-320L | In distribution | |
| TI-1457L-10-320R | In distribution | |
| TI-1457L-13-440L | In distribution | |
| TI-1457S-13-240 | In distribution | |
| TI-1457L-09-360R | In distribution | |
| TI-1457L-10-380R | In distribution | |
| TI-1457L-10-440L | In distribution | |
| TI-1457S-10-200 | In distribution | |
| TI-1457L-10-320L | In distribution | |
| TI-1457L-11-420R | In distribution | |
| TI-1457L-13-380L | In distribution | |
| TI-1457L-11-340R | In distribution | |
| TI-1457L-09-320L | In distribution | |
| TI-1457S-11-240 | In distribution | |
| TI-1457S-09-240 | In distribution | |
| TI-1457S-12-220 | In distribution | |
| TI-1457S-13-180 | In distribution | |
| TI-1457S-11-220 | In distribution | |
| TI-1457L-13-400L | In distribution | |
| TI-1457L-09-440L | In distribution | |
| TI-1457L-10-360L | In distribution | |
| TI-1457L-13-420L | In distribution | |
| TI-1457L-11-320R | In distribution | |
| TI-1457L-11-340L | In distribution | |
| TI-1457L-09-420R | In distribution | |
| TI-1457L-10-420L | In distribution | |
| TI-1457L-09-400L | In distribution | |
| TI-1457L-12-380R | In distribution | |
| TI-1457L-12-420L | In distribution | |
| TI-1457S-13-220 | In distribution | |
| TI-1457S-10-180 | In distribution | |
| TI-1457L-09-360L | In distribution | |
| TI-1457L-10-440R | In distribution | |
| TI-1457L-13-340R | In distribution | |
| TI-1457L-10-340L | In distribution | |
| TI-1457L-10-420R | In distribution | |
| TI-1457L-11-420L | In distribution | |
| TI-1457L-11-400L | In distribution | |
| TI-1457L-13-340L | In distribution | |
| TI-1457L-09-440R | In distribution | |
| TI-1457S-12-180 | In distribution | |
| TI-1457S-10-220 | In distribution | |
| TI-1457L-11-440R | In distribution | |
| TI-1457L-11-400R | In distribution | |
| TI-1457S-09-220 | In distribution | |
| TI-1457L-11-360L | In distribution | |
| TI-1457S-09-200 | In distribution | |
| TI-1457L-09-420L | In distribution | |
| TI-1457L-12-360R | In distribution | |
| TI-1457L-13-400R | In distribution | |
| TI-1457L-10-340R | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192003 | 2020-06-10 |
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.