The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Porous, Ha/tcp, Uncemented Femoral And Tibial Baseplate Components.
| Device ID | K041100 |
| 510k Number | K041100 |
| Device Name: | NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE 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 | Dalene T Binkley |
| Correspondent | Dalene T Binkley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-27 |
| Decision Date | 2004-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024259690 | K041100 | 000 |
| 00889024259607 | K041100 | 000 |
| 00889024259591 | K041100 | 000 |
| 00889024259584 | K041100 | 000 |
| 00889024259577 | K041100 | 000 |
| 00889024259560 | K041100 | 000 |
| 00889024259553 | K041100 | 000 |
| 00889024259546 | K041100 | 000 |
| 00889024259713 | K041100 | 000 |
| 00889024259621 | K041100 | 000 |
| 00889024259638 | K041100 | 000 |
| 00889024259683 | K041100 | 000 |
| 00889024259676 | K041100 | 000 |
| 00889024259669 | K041100 | 000 |
| 00889024259614 | K041100 | 000 |
| 00889024259539 | K041100 | 000 |
| 00889024259522 | K041100 | 000 |
| 00889024259652 | K041100 | 000 |
| 00889024259645 | K041100 | 000 |
| 00889024259706 | K041100 | 000 |