K931617 is an FDA 510(k) clearance for the EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II - Special Controls, product code LZO).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on June 14, 1994, 438 days after receiving the submission on April 2, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K931617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | April 02, 1993 |
| Decision Date | June 14, 1994 |
| Days to Decision | 438 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |