The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Smith & Nephew Visionaire Adaptive Guides.
| Device ID | K170282 |
| 510k Number | K170282 |
| Device Name: | Smith & Nephew VISIONAIRE Adaptive Guides |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals Smith & Nephew, Inc 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-30 |
| Decision Date | 2017-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556658499 | K170282 | 000 |
| 00885556656532 | K170282 | 000 |
| 00885556656525 | K170282 | 000 |
| 00885556656518 | K170282 | 000 |
| 00885556656419 | K170282 | 000 |
| 00885556656402 | K170282 | 000 |
| 00885556656396 | K170282 | 000 |
| 00885556656389 | K170282 | 000 |
| 00885556656372 | K170282 | 000 |
| 00885556656365 | K170282 | 000 |
| 00885556656358 | K170282 | 000 |
| 00885556656341 | K170282 | 000 |
| 00885556656273 | K170282 | 000 |
| 00885556656549 | K170282 | 000 |
| 00885556656556 | K170282 | 000 |
| 00885556656563 | K170282 | 000 |
| 00885556658482 | K170282 | 000 |
| 00885556658475 | K170282 | 000 |
| 00885556658468 | K170282 | 000 |
| 00885556658451 | K170282 | 000 |
| 00885556658444 | K170282 | 000 |
| 00885556658437 | K170282 | 000 |
| 00885556658420 | K170282 | 000 |
| 00885556658413 | K170282 | 000 |
| 00885556658406 | K170282 | 000 |
| 00885556658390 | K170282 | 000 |
| 00885556656587 | K170282 | 000 |
| 00885556656570 | K170282 | 000 |
| 00885556656266 | K170282 | 000 |