Washer, Bolt Nut
5.0MM TI Dual Core Lckng Screw T25 Stardrive 55MM F/IM Nails
9manufacturers in China registered for this device type
88catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HTN |
| Device type | Washer, Bolt Nut |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K040762 |
| Record published | 2015-09-14 |
| Record revised | 2026-06-17 (version 8) |
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 | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 04.015.545 | In distribution | ||
| 419.89 | In distribution | ||
| 04.015.520S | In distribution | ||
| 04.015.555 | In distribution | ||
| 402.627 | In distribution | ||
| 219.951 | In distribution | ||
| 402.619 | In distribution | ||
| 402.729 | In distribution | ||
| 219.97 | In distribution | ||
| 04.015.545S | In distribution | ||
| 202.619 | In distribution | ||
| 202.624 | In distribution | ||
| 04.015.525 | In distribution | ||
| 402.615 | In distribution | ||
| 402.613 | In distribution | ||
| 402.620 | In distribution | ||
| 202.612 | In distribution | ||
| 04.221.003S | In distribution | ||
| 202.721 | In distribution | ||
| 202.634 | In distribution | ||
| 419.99 | In distribution | ||
| 402.617 | In distribution | ||
| 402.721 | In distribution | ||
| 219.941 | In distribution | ||
| 419.972 | In distribution | ||
| 402.608 | In distribution | ||
| 202.718 | In distribution | ||
| 219.931 | In distribution | ||
| 202.632 | In distribution | ||
| 402.732 | In distribution | ||
| 402.736 | In distribution | ||
| 402.629 | In distribution | ||
| 498.804 | 5 | In distribution | |
| 202.719 | In distribution | ||
| 02.221.003S | In distribution | ||
| 402.730 | In distribution | ||
| 219.99 | In distribution | ||
| 402.740 | In distribution | ||
| 402.614 | In distribution | ||
| 202.630 | In distribution | ||
| 402.716 | In distribution | ||
| 402.621 | In distribution | ||
| 04.015.520 | In distribution | ||
| 202.614 | In distribution | ||
| 02.221.004S | In distribution | ||
| 202.738 | In distribution | ||
| 202.640 | In distribution | ||
| 202.608 | In distribution | ||
| 419.96 | In distribution | ||
| 402.722 | In distribution | ||
| 202.725 | In distribution | ||
| 419.98 | In distribution | ||
| 219.91 | In distribution | ||
| 402.616 | In distribution | ||
| 04.221.002S | In distribution | ||
| 402.612 | In distribution | ||
| 419.91 | In distribution | ||
| 219.96 | In distribution | ||
| 04.015.580 | In distribution | ||
| 402.628 | In distribution | ||
| 402.609 | In distribution | ||
| 402.723 | In distribution | ||
| 202.730 | In distribution | ||
| 402.714 | In distribution | ||
| 202.611 | In distribution | ||
| 402.630 | In distribution | ||
| 202.723 | In distribution | ||
| 04.015.575S | In distribution | ||
| 04.015.540 | In distribution | ||
| 202.625 | In distribution | ||
| 402.638 | In distribution | ||
| 202.609 | In distribution | ||
| 402.720 | In distribution | ||
| 498.805 | 5 | In distribution | |
| 04.015.560S | In distribution | ||
| 04.015.530 | In distribution | ||
| 219.98 | In distribution | ||
| 219.972 | In distribution | ||
| 04.015.570S | In distribution | ||
| 04.015.565 | In distribution | ||
| 202.715 | In distribution | ||
| 402.717 | In distribution | ||
| 298.805 | 5 | In distribution | |
| 04.015.560 | In distribution | ||
| 04.221.004S | In distribution | ||
| 402.726 | In distribution | ||
| SD219.002 | Withdrawn | ||
| SD219.001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Washer, Bolt Nut | Zimmer, Inc. | 308 |
| MaxTorque™ | Tornier Inc. | 171 |
| Arthrex® | Arthrex, Inc. | 154 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 92 |
| A.l.p.s.® | Biomet Orthopedics | 67 |
| Variax | Stryker GmbH | 59 |
| Conmed | ConMed Corporation | 38 |
| Neoortho | Neoortho Produtos Ortopédicos S/A | 32 |
| Aptus | Medartis Inc. | 31 |
| AC Device | Lockdown Medical Limited | 31 |
| Evos | Smith & Nephew, Inc. | 28 |
| Axis | Extremity Medical, LLC | 26 |
Showing 12 of 304. All products under Washer, Bolt Nut
Recalls Naming This Product
3 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 Gmbh | 510(k) number | 2014-06-30 | Class II | Employee error | A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic. | 4 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-10-03 | Class II | Finished device change control | During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. | 3087 | 2015-12-18 |
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.