Evos
Evos 2.4MM T-Plate Template 3 Hole Head 5 Hole Shaft
9manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HTN |
| Device type | Washer, Bolt Nut |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K162078 |
| Record published | 2017-02-23 |
| Record revised | 2025-11-20 (version 11) |
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 |
|---|---|---|
| 72440218N | In distribution | |
| 76112478 | In distribution | |
| 72442135N | In distribution | |
| 72440310N | In distribution | |
| 70899290 | Diameter: 9.0 Millimeter | In distribution |
| 72440622N | In distribution | |
| 72441020 | In distribution | |
| 72440308N | In distribution | |
| 72440106N | In distribution | |
| 76112786 | In distribution | |
| 72440315N | In distribution | |
| 70899291 | Diameter: 9.0 Millimeter | In distribution |
| 72442235 | In distribution | |
| 76112472 | In distribution | |
| 72442235N | In distribution | |
| 76112072 | In distribution | |
| 76112462 | In distribution | |
| 72440208 | In distribution | |
| 76112454 | In distribution | |
| 76112778 | In distribution | |
| 72440710 | In distribution | |
| 76112054 | In distribution | |
| 72440708N | In distribution | |
| 76112728 | In distribution | |
| 72441008N | In distribution | |
| 72440304N | In distribution | |
| 76112468 | In distribution | |
| 72440408N | 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 |
| Neoortho | Neoortho Produtos Ortopédicos S/A | 32 |
| Aptus | Medartis Inc. | 31 |
| AC Device | Lockdown Medical Limited | 31 |
| Axis | Extremity Medical, LLC | 26 |
Showing 12 of 304. All products under Washer, Bolt Nut
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162996 | 2017-06-08 |
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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2021-10-25 | Class II | Error in labeling | The labels on the packages of screws were switched. | 224 units | |
| Smith & Nephew, Inc. | 510(k) number | 2020-08-24 | Class II | Error in labeling | Multiple or incorrect expiration dates were provided on the affected designation labels. | 71 units | 2022-07-11 |
| Smith & Nephew, Inc. | 510(k) number | 2017-11-29 | Class II | Employee error | One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. | 12 | 2020-09-01 |
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.