Neoortho
SS Tooth Lockwasher D3.5 mm
9manufacturers in China registered for this device type
32catalogue 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 | Neoortho Produtos Ortopédicos S/A, Brazil |
|---|---|
| FDA product code | HTN |
| Device type | Washer, Bolt Nut |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K162874 |
| Record published | 2018-10-24 |
| Record revised | 2023-09-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 907.788 | In distribution | |
| 911.373 | In distribution | |
| 907.791 | In distribution | |
| 907.786 | In distribution | |
| 907.833 | In distribution | |
| 907.796 | In distribution | |
| 911.369 | In distribution | |
| 911.370 | In distribution | |
| 911.363 | In distribution | |
| 911.374 | In distribution | |
| 911.367 | In distribution | |
| 907.793 | In distribution | |
| 907.783 | In distribution | |
| 907.790 | In distribution | |
| 911.364 | In distribution | |
| 907.789 | In distribution | |
| 911.377 | In distribution | |
| 911.372 | In distribution | |
| 907.785 | In distribution | |
| 907.795 | In distribution | |
| 907.794 | In distribution | |
| 911.378 | In distribution | |
| 911.375 | In distribution | |
| 911.366 | In distribution | |
| 907.787 | In distribution | |
| 911.376 | In distribution | |
| 911.371 | In distribution | |
| 907.792 | In distribution | |
| 907.784 | In distribution | |
| 911.368 | In distribution | |
| 907.834 | In distribution | |
| 911.365 | In distribution |
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 |
| Washer, Bolt Nut | Synthes Gmbh | 88 |
| A.l.p.s.® | Biomet Orthopedics | 67 |
| Variax | Stryker GmbH | 59 |
| Conmed | ConMed Corporation | 38 |
| 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
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.