The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution Lps-flex And Knee Gender Solutions Female (gsf) Porous Femoral Components.
| Device ID | K072619 |
| 510k Number | K072619 |
| Device Name: | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS |
| 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 | Daniel J Williman |
| Correspondent | Daniel J Williman 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 | 2007-09-17 |
| Decision Date | 2007-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024210721 | K072619 | 000 |
| 00889024191419 | K072619 | 000 |
| 00889024191426 | K072619 | 000 |
| 00889024191457 | K072619 | 000 |
| 00889024191464 | K072619 | 000 |
| 00889024191495 | K072619 | 000 |
| 00889024191501 | K072619 | 000 |
| 00889024192119 | K072619 | 000 |
| 00889024192126 | K072619 | 000 |
| 00889024191372 | K072619 | 000 |
| 00889024191365 | K072619 | 000 |
| 00889024191358 | K072619 | 000 |
| 00889024210738 | K072619 | 000 |
| 00889024210752 | K072619 | 000 |
| 00889024210776 | K072619 | 000 |
| 00889024210783 | K072619 | 000 |
| 00889024191310 | K072619 | 000 |
| 00889024191327 | K072619 | 000 |
| 00889024191334 | K072619 | 000 |
| 00889024191341 | K072619 | 000 |
| 00889024192133 | K072619 | 000 |
| 00889024192140 | K072619 | 000 |
| 00889024192195 | K072619 | 000 |
| 00889024192201 | K072619 | 000 |
| 00889024210745 | K072619 | 000 |
| 00889024210769 | K072619 | 000 |
| 00889024210790 | K072619 | 000 |
| 00889024210806 | K072619 | 000 |
| 00889024210813 | K072619 | 000 |
| 00889024210820 | K072619 | 000 |
| 00889024191488 | K072619 | 000 |
| 00889024191471 | K072619 | 000 |
| 00889024191440 | K072619 | 000 |
| 00889024192157 | K072619 | 000 |
| 00889024192164 | K072619 | 000 |
| 00889024192171 | K072619 | 000 |
| 00889024192188 | K072619 | 000 |
| 00889024191389 | K072619 | 000 |
| 00889024191396 | K072619 | 000 |
| 00889024191402 | K072619 | 000 |
| 00889024191433 | K072619 | 000 |
| 00889024210837 | K072619 | 000 |