K934515 is an FDA 510(k) clearance for the BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB). 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 March 7, 1995, 538 days after receiving the submission on September 15, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K934515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1993 |
| Decision Date | March 07, 1995 |
| Days to Decision | 538 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 |