The following data is part of a premarket notification filed by Zimmer, Inc with the FDA for Zimmer Biomet Select Ceramic Heads.
| Device ID | K181761 |
| 510k Number | K181761 |
| Device Name: | Zimmer Biomet Select Ceramic Heads |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Zimmer, Inc PO Box 708 Warsaw, IN 46581 -0708 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling Zimmer, Inc PO Box 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2018-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024500471 | K181761 | 000 |
| 00889024500358 | K181761 | 000 |
| 00889024500341 | K181761 | 000 |
| 00889024500334 | K181761 | 000 |
| 00889024500327 | K181761 | 000 |
| 00889024500303 | K181761 | 000 |
| 00889024500297 | K181761 | 000 |
| 00889024500280 | K181761 | 000 |
| 00889024500273 | K181761 | 000 |
| 00889024500365 | K181761 | 000 |
| 00889024500372 | K181761 | 000 |
| 00889024500389 | K181761 | 000 |
| 00889024500464 | K181761 | 000 |
| 00889024500457 | K181761 | 000 |
| 00889024500440 | K181761 | 000 |
| 00889024500433 | K181761 | 000 |
| 00889024500426 | K181761 | 000 |
| 00889024500419 | K181761 | 000 |
| 00889024500402 | K181761 | 000 |
| 00889024500396 | K181761 | 000 |
| 00889024500266 | K181761 | 000 |