The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Gender Solutions Natural-knee Flex System; Nex Gen Complete Knee Solution Cr-flex Gender Solutions Female Femoral Compon.
| Device ID | K071107 |
| 510k Number | K071107 |
| Device Name: | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-19 |
| Decision Date | 2007-07-06 |
| Summary: | summary |