The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Competitor Duo Knee Femoral.
| Device ID | K052265 |
| 510k Number | K052265 |
| Device Name: | SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL |
| Classification | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Gino J Rouss |
| Correspondent | Gino J Rouss SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | NPJ |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-19 |
| Decision Date | 2005-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010582393 | K052265 | 000 |
| 03596010581907 | K052265 | 000 |
| 03596010581891 | K052265 | 000 |
| 03596010581884 | K052265 | 000 |
| 03596010581877 | K052265 | 000 |
| 03596010581860 | K052265 | 000 |
| 03596010581853 | K052265 | 000 |
| 03596010581846 | K052265 | 000 |
| 03596010581839 | K052265 | 000 |
| 03596010581822 | K052265 | 000 |
| 03596010581815 | K052265 | 000 |
| 03596010581914 | K052265 | 000 |
| 03596010582287 | K052265 | 000 |
| 03596010582386 | K052265 | 000 |
| 03596010582379 | K052265 | 000 |
| 03596010582362 | K052265 | 000 |
| 03596010582355 | K052265 | 000 |
| 03596010582348 | K052265 | 000 |
| 03596010582331 | K052265 | 000 |
| 03596010582324 | K052265 | 000 |
| 03596010582317 | K052265 | 000 |
| 03596010582300 | K052265 | 000 |
| 03596010582294 | K052265 | 000 |
| 03596010581808 | K052265 | 000 |