The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/l Taper Hip Prosthesis.
| Device ID | K161830 |
| 510k Number | K161830 |
| Device Name: | Zimmer M/L Taper Hip Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2016-10-26 |
| Summary: | summary |