The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Genesis Ii Total Knee System.
| Device ID | K030612 |
| 510k Number | K030612 |
| Device Name: | GENESIS II TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Kim P Kelley |
| Correspondent | Kim P Kelley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-26 |
| Decision Date | 2003-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556056875 | K030612 | 000 |
| 03596010496430 | K030612 | 000 |
| 03596010496423 | K030612 | 000 |
| 03596010496416 | K030612 | 000 |
| 03596010496409 | K030612 | 000 |
| 03596010496393 | K030612 | 000 |
| 03596010496386 | K030612 | 000 |
| 03596010496379 | K030612 | 000 |
| 03596010496355 | K030612 | 000 |
| 03596010496348 | K030612 | 000 |
| 03596010496331 | K030612 | 000 |
| 03596010496324 | K030612 | 000 |
| 03596010496294 | K030612 | 000 |
| 03596010496287 | K030612 | 000 |
| 03596010496270 | K030612 | 000 |
| 03596010496263 | K030612 | 000 |
| 03596010496249 | K030612 | 000 |
| 03596010496232 | K030612 | 000 |
| 03596010496447 | K030612 | 000 |
| 03596010496454 | K030612 | 000 |
| 03596010608819 | K030612 | 000 |
| 00885556056769 | K030612 | 000 |
| 00885556056431 | K030612 | 000 |
| 00885556056356 | K030612 | 000 |
| 00885556056080 | K030612 | 000 |
| 00885556056035 | K030612 | 000 |
| 00885556056011 | K030612 | 000 |
| 00885556055786 | K030612 | 000 |
| 00885556055670 | K030612 | 000 |
| 00885556055632 | K030612 | 000 |
| 00885556055526 | K030612 | 000 |
| 00885556055410 | K030612 | 000 |
| 00885556030479 | K030612 | 000 |
| 03596010496362 | K030612 | 000 |
| 03596010496317 | K030612 | 000 |
| 03596010496300 | K030612 | 000 |
| 03596010496256 | K030612 | 000 |
| 03596010496225 | K030612 | 000 |
| 03596010496218 | K030612 | 000 |