The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Delta Hip Prosthesis.
| Device ID | K961378 |
| 510k Number | K961378 |
| Device Name: | DELTA HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Karen Cain |
| Correspondent | Karen Cain ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-10 |
| Decision Date | 1996-10-08 |
| Summary: | summary |