The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Knee Gender Solutions Female (gsf) Femoral Components.
| Device ID | K060370 |
| 510k Number | K060370 |
| Device Name: | NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen Mckelvey |
| Correspondent | Stephen Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024191303 | K060370 | 000 |
| 00889024191129 | K060370 | 000 |
| 00889024192300 | K060370 | 000 |
| 00889024192294 | K060370 | 000 |
| 00889024192287 | K060370 | 000 |
| 00889024192270 | K060370 | 000 |
| 00889024192263 | K060370 | 000 |
| 00889024192256 | K060370 | 000 |
| 00889024192249 | K060370 | 000 |
| 00889024192232 | K060370 | 000 |
| 00889024192225 | K060370 | 000 |
| 00889024192218 | K060370 | 000 |
| 00889024191167 | K060370 | 000 |
| 00889024191136 | K060370 | 000 |
| 00889024191143 | K060370 | 000 |
| 00889024191150 | K060370 | 000 |
| 00889024191297 | K060370 | 000 |
| 00889024191280 | K060370 | 000 |
| 00889024191273 | K060370 | 000 |
| 00889024191266 | K060370 | 000 |
| 00889024191259 | K060370 | 000 |
| 00889024191242 | K060370 | 000 |
| 00889024191235 | K060370 | 000 |
| 00889024191228 | K060370 | 000 |
| 00889024191211 | K060370 | 000 |
| 00889024191204 | K060370 | 000 |
| 00889024191198 | K060370 | 000 |
| 00889024191181 | K060370 | 000 |
| 00889024191174 | K060370 | 000 |
| 00889024191112 | K060370 | 000 |