Pin, Fixation, Threaded
4.0MM Locking Screw SLF-Tpng With T25 Stardrive Recess 30MM
9manufacturers in China registered for this device type
71catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K040765 |
| Record published | 2015-09-14 |
| Record revised | 2025-02-06 (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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 02.207.105 | In distribution | ||
| 02.207.040 | In distribution | ||
| 02.205.110 | In distribution | ||
| 02.204.030 | In distribution | ||
| 293.42 | In distribution | ||
| 02.207.125 | In distribution | ||
| 02.207.070 | In distribution | ||
| 02.205.120 | In distribution | ||
| 02.207.025 | In distribution | ||
| 02.207.060 | In distribution | ||
| 02.205.105 | In distribution | ||
| 02.204.054 | In distribution | ||
| 296.766 | In distribution | ||
| 02.207.130 | In distribution | ||
| SD496.001 | In distribution | ||
| 02.205.030 | In distribution | ||
| 02.207.035 | In distribution | ||
| 02.207.095 | In distribution | ||
| 02.207.120 | In distribution | ||
| 02.205.100 | In distribution | ||
| 02.205.115 | In distribution | ||
| 03.010.115 | In distribution | ||
| 02.207.485 | In distribution | ||
| 02.207.020 | In distribution | ||
| 293.940 | In distribution | ||
| 296.758 | 2 | In distribution | |
| 02.207.100 | In distribution | ||
| 02.207.115 | In distribution | ||
| 02.207.505 | In distribution | ||
| 293.41 | In distribution | ||
| 02.207.530 | In distribution | ||
| 293.35 | In distribution | ||
| 494.769 | In distribution | ||
| 02.205.130 | In distribution | ||
| SD496.003 | In distribution | ||
| 02.204.062 | In distribution | ||
| 02.207.145 | In distribution | ||
| 02.205.045 | In distribution | ||
| 02.205.140 | In distribution | ||
| 900.726 | In distribution | ||
| 292.79 | 10 | In distribution | |
| 02.207.135 | In distribution | ||
| 357.039 | In distribution | ||
| 02.207.055 | In distribution | ||
| SD496.002 | In distribution | ||
| 02.207.515 | In distribution | ||
| 02.207.460 | In distribution | ||
| 02.205.145 | In distribution | ||
| 02.205.040 | In distribution | ||
| 02.205.125 | In distribution | ||
| 02.207.110 | In distribution | ||
| 02.205.295 | In distribution | ||
| 293.890 | In distribution | ||
| 02.205.260 | In distribution | ||
| 02.207.045 | In distribution | ||
| 02.207.140 | In distribution | ||
| 296.757 | 2 | In distribution | |
| 02.205.095 | In distribution | ||
| 296.759 | 2 | In distribution | |
| 02.205.255 | In distribution | ||
| 199.936S | In distribution | ||
| 02.207.030 | In distribution | ||
| 296.763 | In distribution | ||
| 02.205.135 | In distribution | ||
| 02.204.050 | In distribution | ||
| 02.204.018 | In distribution | ||
| 293.40 | In distribution | ||
| 02.207.450 | In distribution | ||
| 02.207.250 | In distribution | ||
| 199.933S | In distribution | ||
| 02.207.520 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
Recalls Naming This Product
6 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 | 2015-07-29 | Class II | Labeling design | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR | 5306080 | 2016-09-27 |
| Synthes Gmbh | 510(k) number | 2014-10-17 | Class II | Labeling design | Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating the | 43159 | 2016-08-18 |
| Synthes Gmbh | 510(k) number | 2014-04-10 | Class II | Labeling Change Control | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. | 5,114,052 | 2016-08-26 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Nonconforming Material/Component | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. | 136 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-10-12 | Class II | Packaging | It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect in | 8 | |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-09-28 | Class II | Labeling mix-ups | The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect. | 8 | 2015-09-21 |
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.