K915617 is an FDA 510(k) clearance for the LSF HA COATED FEMORAL HIP. 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 Implant Technology, Inc. (Secaucus, US). The FDA issued a Cleared decision on May 28, 1992, 164 days after receiving the submission on December 16, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K915617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1991 |
| Decision Date | May 28, 1992 |
| Days to Decision | 164 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 |