The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Threaded Acetabular Cup.
| Device ID | K850766 |
| 510k Number | K850766 |
| Device Name: | ZIMMER THREADED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Max Sherman |
| Correspondent | Max Sherman ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-05-01 |