The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Gender Solutions Natural-knee Flex System.
| Device ID | K073286 |
| 510k Number | K073286 |
| Device Name: | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Brandon Hipsher |
| Correspondent | Brandon Hipsher ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| Subsequent Product Code | KRR |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-21 |
| Decision Date | 2008-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024573666 | K073286 | 000 |
| 00889024573659 | K073286 | 000 |
| 00889024573642 | K073286 | 000 |
| 00889024573635 | K073286 | 000 |
| 00889024189454 | K073286 | 000 |
| 00889024189447 | K073286 | 000 |
| 00889024189430 | K073286 | 000 |
| 00889024189423 | K073286 | 000 |