K921557 is an FDA 510(k) clearance for the BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 22, 1994, 692 days after receiving the submission on April 1, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K921557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 01, 1992 |
| Decision Date | February 22, 1994 |
| Days to Decision | 692 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |