K912369 is an FDA 510(k) clearance for the HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT). This device is classified as a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II - Special Controls, product code MEH).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 11, 1991, 135 days after receiving the submission on May 29, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K912369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1991 |
| Decision Date | October 11, 1991 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |