The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Tibial Routers, Femoral Routers And Tube Graft Sizer.
| Device ID | K946313 |
| 510k Number | K946313 |
| Device Name: | TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER |
| Classification | Arthroscope |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Contact | Dan W Miller |
| Correspondent | Dan W Miller SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-28 |
| Decision Date | 1995-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556600368 | K946313 | 000 |
| 03596010473271 | K946313 | 000 |
| 03596010473264 | K946313 | 000 |
| 03596010473257 | K946313 | 000 |
| 03596010473240 | K946313 | 000 |
| 03596010473233 | K946313 | 000 |
| 03596010473226 | K946313 | 000 |
| 03596010473219 | K946313 | 000 |
| 03596010253330 | K946313 | 000 |
| 03596010253323 | K946313 | 000 |
| 03596010473288 | K946313 | 000 |
| 03596010473295 | K946313 | 000 |
| 03596010473301 | K946313 | 000 |
| 00885556600344 | K946313 | 000 |
| 00885556600337 | K946313 | 000 |
| 00885556600320 | K946313 | 000 |
| 00885556600306 | K946313 | 000 |
| 00885556600283 | K946313 | 000 |
| 00885556569580 | K946313 | 000 |
| 00885556568545 | K946313 | 000 |
| 00885556568538 | K946313 | 000 |
| 00885554038729 | K946313 | 000 |
| 03596010253316 | K946313 | 000 |