K901297 is an FDA 510(k) clearance for the EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP. 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 May 2, 1990, 43 days after receiving the submission on March 20, 1990.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K901297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | March 20, 1990 |
| Decision Date | May 02, 1990 |
| Days to Decision | 43 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 |