The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segmental System Proximal Femoral Component.
| Device ID | K183136 |
| 510k Number | K183136 |
| Device Name: | Zimmer Segmental System Proximal Femoral Component |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Jason Heckaman |
| Correspondent | Jason Heckaman Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-01-30 |
| Summary: | summary |