K883212 is an FDA 510(k) clearance for the LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT. This device is classified as a Prosthesis, Hip, Femoral, Resurfacing (Class II - Special Controls, product code KXA).
Submitted by Implant Technology, Inc. (Secaucus, US). The FDA issued a Cleared decision on November 22, 1988, 116 days after receiving the submission on July 29, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3400.
| 510(k) Number | K883212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1988 |
| Decision Date | November 22, 1988 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KXA — Prosthesis, Hip, Femoral, Resurfacing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3400 |