The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Competitor Unicondylar Knee Tibial Baseplate.
| Device ID | K061011 |
| 510k Number | K061011 |
| Device Name: | COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Gino Rouss |
| Correspondent | Gino Rouss SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-12 |
| Decision Date | 2006-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010620521 | K061011 | 000 |
| 03596010582140 | K061011 | 000 |
| 03596010582133 | K061011 | 000 |
| 03596010582119 | K061011 | 000 |
| 03596010582102 | K061011 | 000 |
| 03596010582096 | K061011 | 000 |
| 03596010582072 | K061011 | 000 |
| 03596010582065 | K061011 | 000 |
| 03596010582041 | K061011 | 000 |
| 03596010620514 | K061011 | 000 |
| 03596010620453 | K061011 | 000 |
| 03596010582218 | K061011 | 000 |
| 03596010582188 | K061011 | 000 |
| 03596010582126 | K061011 | 000 |
| 03596010582089 | K061011 | 000 |
| 03596010582157 | K061011 | 000 |
| 03596010582164 | K061011 | 000 |
| 03596010620491 | K061011 | 000 |
| 03596010620484 | K061011 | 000 |
| 03596010620477 | K061011 | 000 |
| 03596010620460 | K061011 | 000 |
| 03596010620446 | K061011 | 000 |
| 03596010582270 | K061011 | 000 |
| 03596010582263 | K061011 | 000 |
| 03596010582256 | K061011 | 000 |
| 03596010582249 | K061011 | 000 |
| 03596010582232 | K061011 | 000 |
| 03596010582225 | K061011 | 000 |
| 03596010582201 | K061011 | 000 |
| 03596010582195 | K061011 | 000 |
| 03596010582171 | K061011 | 000 |
| 03596010582058 | K061011 | 000 |