Nail, Fixation, Bone
LOW Prof Lckng Screw F/IM Nail Ø 4.0MM / L 24MM / XL25/ Ster
3manufacturers in China registered for this device type
296catalogue 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) | K201336 |
| Record published | 2021-05-07 |
| Record revised | 2025-02-06 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.043.540S | In distribution | |
| 04.045.072 | In distribution | |
| 422.390 | In distribution | |
| 04.043.470S | In distribution | |
| 04.045.524TS | In distribution | |
| 462.634S | In distribution | |
| 04.045.374 | In distribution | |
| 03.010.441 | In distribution | |
| 04.045.256 | In distribution | |
| 04.043.375S | In distribution | |
| 04.043.120S | In distribution | |
| 04.045.264TS | In distribution | |
| 04.043.515S | In distribution | |
| 04.045.032TS | In distribution | |
| 04.045.395TS | In distribution | |
| 422.340 | In distribution | |
| 04.045.260TS | In distribution | |
| 04.045.384S | In distribution | |
| SD03.043.029 | In distribution | |
| 04.043.270S | In distribution | |
| 04.015.565S | In distribution | |
| 04.045.038S | In distribution | |
| SD03.010.531 | In distribution | |
| 04.043.310S | In distribution | |
| 03.010.456 | In distribution | |
| 04.043.465S | In distribution | |
| 204.890 | In distribution | |
| 04.045.522 | In distribution | |
| 462.650S | In distribution | |
| 04.045.574 | In distribution | |
| 04.045.326S | In distribution | |
| 04.045.120 | In distribution | |
| 04.001.008S | In distribution | |
| 04.045.570S | In distribution | |
| 04.045.386TS | In distribution | |
| 04.015.577S | In distribution | |
| 04.045.576TS | In distribution | |
| 04.045.405S | In distribution | |
| 04.015.550 | In distribution | |
| 04.043.060S | In distribution | |
| 04.045.066 | In distribution | |
| 04.045.332TS | In distribution | |
| 04.045.546 | In distribution | |
| 422.393 | In distribution | |
| 04.045.252TS | In distribution | |
| 04.043.265S | In distribution | |
| 04.045.534 | In distribution | |
| 04.045.262S | In distribution | |
| 04.045.090TS | In distribution | |
| 03.010.455 | In distribution | |
| 04.045.105 | In distribution | |
| 04.045.095TS | In distribution | |
| 462.648S | In distribution | |
| 04.045.546S | In distribution | |
| 04.043.170S | In distribution | |
| 04.043.075S | In distribution | |
| 462.636S | In distribution | |
| 04.045.232 | In distribution | |
| 04.043.545S | In distribution | |
| 462.654S | In distribution | |
| 04.045.252 | In distribution | |
| 04.045.068S | In distribution | |
| 04.043.455S | In distribution | |
| 04.043.520S | In distribution | |
| 04.015.540S | In distribution | |
| 04.045.420TS | In distribution | |
| 04.043.035S | In distribution | |
| 04.015.552S | In distribution | |
| 03.010.438S | In distribution | |
| 04.045.348 | In distribution | |
| 04.045.224 | In distribution | |
| 04.045.405TS | In distribution | |
| 04.045.542TS | In distribution | |
| 04.015.525S | In distribution | |
| 204.840 | In distribution | |
| 04.015.575 | In distribution | |
| 04.045.272TS | In distribution | |
| 03.010.436 | In distribution | |
| 04.015.555S | In distribution | |
| 422.391 | In distribution | |
| 462.648 | In distribution | |
| 04.045.066TS | In distribution | |
| 04.043.570S | In distribution | |
| 03.010.442 | In distribution | |
| 458.120 | In distribution | |
| 04.015.537S | In distribution | |
| 212.128 | In distribution | |
| 04.045.250TS | In distribution | |
| 04.045.336 | In distribution | |
| 04.045.032 | In distribution | |
| 04.015.580S | In distribution | |
| 04.045.090 | In distribution | |
| 04.045.526S | In distribution | |
| 04.043.405S | In distribution | |
| 04.045.568 | In distribution | |
| 04.045.534S | In distribution | |
| 04.045.530 | In distribution | |
| 04.043.130S | In distribution | |
| 462.652 | In distribution | |
| 04.043.440S | In distribution | |
| 04.045.326TS | In distribution | |
| 04.015.572S | In distribution | |
| 04.045.070TS | In distribution | |
| 04.001.007S | In distribution | |
| 204.820 | In distribution | |
| 03.010.433 | In distribution | |
| 04.045.576S | In distribution | |
| 204.855 | In distribution | |
| 04.045.228 | In distribution | |
| 422.344 | In distribution | |
| 212.116 | In distribution | |
| 212.125 | In distribution | |
| 04.045.036TS | In distribution | |
| 04.045.030S | In distribution | |
| 04.043.240S | In distribution | |
| 422.396 | In distribution | |
| 04.045.230S | In distribution | |
| 04.045.556TS | In distribution | |
| 04.043.420S | In distribution | |
| 04.015.532S | In distribution | |
| 04.043.245S | In distribution | |
| 04.045.518S | In distribution | |
| 04.045.400S | In distribution | |
| 04.045.080 | In distribution | |
| 04.045.572TS | In distribution | |
| 04.045.338S | In distribution | |
| SD03.043.031 | In distribution | |
| 04.045.354S | In distribution | |
| 04.045.536 | In distribution | |
| 04.045.338 | In distribution | |
| 04.045.278S | In distribution | |
| 04.045.072TS | In distribution | |
| 04.045.572 | In distribution | |
| 212.131 | In distribution | |
| 04.045.258TS | In distribution | |
| 04.045.050TS | In distribution | |
| 03.010.095 | In distribution | |
| 04.015.557S | In distribution | |
| 04.015.550S | In distribution | |
| 04.045.076 | In distribution | |
| 04.045.544S | In distribution | |
| 04.045.552 | In distribution | |
| 04.045.568S | In distribution | |
| 462.642S | In distribution | |
| 04.045.376S | In distribution | |
| 04.043.370S | In distribution | |
| 04.043.360S | In distribution | |
| 04.045.346S | In distribution | |
| 04.045.274TS | In distribution | |
| 212.109 | In distribution | |
| 04.045.270TS | In distribution | |
| 04.043.320S | In distribution | |
| 04.043.025S | In distribution | |
| 04.045.242 | In distribution | |
| 04.045.340TS | In distribution | |
| 04.045.526TS | In distribution | |
| 04.043.155S | In distribution | |
| 04.045.230TS | In distribution | |
| 462.636 | In distribution | |
| 04.045.032S | In distribution | |
| 04.045.260 | In distribution | |
| 04.015.542S | In distribution | |
| 04.001.010S | In distribution | |
| 04.045.342S | In distribution | |
| 04.045.388 | In distribution | |
| 04.045.220S | In distribution | |
| 04.045.540TS | In distribution | |
| 04.045.234 | In distribution | |
| 04.045.078S | In distribution | |
| 04.045.086 | In distribution | |
| 204.900 | In distribution | |
| 04.043.210S | In distribution | |
| 462.642 | In distribution | |
| 04.045.246 | In distribution | |
| 204.895 | In distribution | |
| 04.045.042S | In distribution | |
| 04.015.567S | In distribution | |
| 212.127 | In distribution | |
| 04.045.100S | In distribution | |
| 03.010.440 | In distribution | |
| 04.045.086S | In distribution | |
| 04.043.015S | In distribution | |
| 212.111 | In distribution | |
| 462.634 | In distribution | |
| 03.010.435 | In distribution | |
| 04.043.435S | In distribution | |
| 04.045.540S | In distribution | |
| 04.043.160S | In distribution | |
| 04.045.262TS | In distribution | |
| 04.045.054TS | In distribution | |
| 212.130 | In distribution | |
| 03.010.434 | In distribution | |
| 04.045.520S | In distribution | |
| 04.043.460S | In distribution | |
| 422.304 | In distribution | |
| 04.015.562S | In distribution | |
| 204.822 | In distribution | |
| 04.045.110 | In distribution | |
| 04.045.254S | In distribution | |
| 04.043.225S | In distribution | |
| 204.834 | In distribution | |
| 462.638 | In distribution | |
| 04.043.215S | In distribution | |
| 04.043.150S | In distribution | |
| 212.115 | In distribution | |
| 04.015.535 | In distribution | |
| 04.045.054S | In distribution | |
| 04.015.527S | In distribution | |
| 204.880 | In distribution | |
| 04.045.110S | In distribution | |
| 04.045.232TS | In distribution | |
| 04.043.340S | In distribution | |
| 04.045.095 | In distribution | |
| 04.045.246TS | In distribution | |
| 04.001.009S | In distribution | |
| 462.640 | In distribution | |
| 04.043.040S | In distribution | |
| 212.113 | In distribution | |
| 04.045.078TS | In distribution | |
| 03.043.024 | In distribution | |
| 04.045.236TS | In distribution | |
| 04.043.020S | In distribution | |
| 04.045.276S | In distribution | |
| 212.105 | In distribution | |
| 04.043.105S | In distribution | |
| 04.045.360S | In distribution | |
| 04.043.275S | In distribution | |
| 04.043.315S | In distribution | |
| 04.045.580TS | In distribution | |
| 04.045.405 | In distribution | |
| 04.045.220TS | In distribution | |
| 03.010.430 | In distribution | |
| 462.644 | In distribution | |
| SD03.010.530 | In distribution | |
| 04.045.558TS | In distribution | |
| 04.045.578TS | In distribution | |
| 462.644S | In distribution | |
| 04.045.370 | In distribution | |
| 04.045.228TS | In distribution | |
| 04.043.450S | In distribution | |
| 422.309 | In distribution | |
| 462.640S | In distribution | |
| 04.045.250 | In distribution | |
| 04.015.522S | In distribution | |
| 04.043.125S | In distribution | |
| 04.045.222 | In distribution | |
| 204.870 | In distribution | |
| 04.043.220S | In distribution | |
| 04.045.550 | In distribution | |
| 04.045.350 | In distribution |
Showing 250 of 296 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Autobahn | Globus Medical, Inc. | 1,102 |
| Trigen | Smith & Nephew, Inc. | 1,062 |
| 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 |
| Expert Femoral Nail | Auxein medical Private limited | 70 |
Showing 12 of 112. All products under Nail, Fixation, Bone
Recalls Naming This Product
7 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 (USA) Products LLC | 510(k) number | 2025-09-26 | Class II | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | 120 units | |
| Synthes (USA) Products LLC | 510(k) number | 2025-09-26 | Class II | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | 122 units | |
| 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) Products LLC | 510(k) number | 2013-10-14 | Class II | Labeling mix-ups | Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. | 55 | 2015-08-18 |
| 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 |
| 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.