K862234 is an FDA 510(k) clearance for the EXACTECH TOTAL HIP SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 15, 1986, 126 days after receiving the submission on June 11, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K862234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | June 11, 1986 |
| Decision Date | October 15, 1986 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |