The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Bias Total Hip System Acetabular Component.
| Device ID | K921557 |
| 510k Number | K921557 |
| Device Name: | BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-01 |
| Decision Date | 1994-02-22 |