The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Trabecular Metal Tibial Tray.
| Device ID | K072160 |
| 510k Number | K072160 |
| Device Name: | NEXGEN TRABECULAR METAL TIBIAL TRAY |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2007-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024208285 | K072160 | 000 |
| 00889024473256 | K072160 | 000 |
| 00889024473263 | K072160 | 000 |
| 00889024473270 | K072160 | 000 |
| 00889024473287 | K072160 | 000 |
| 00889024473294 | K072160 | 000 |
| 00889024473300 | K072160 | 000 |
| 00889024473317 | K072160 | 000 |
| 00889024473324 | K072160 | 000 |
| 00889024208247 | K072160 | 000 |
| 00889024208230 | K072160 | 000 |
| 00889024208254 | K072160 | 000 |
| 00889024208261 | K072160 | 000 |
| 00889024208278 | K072160 | 000 |
| 00889024208292 | K072160 | 000 |
| 00889024208315 | K072160 | 000 |
| 00889024473249 | K072160 | 000 |