K895607 is an FDA 510(k) clearance for the POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III - Premarket Approval, product code JDL).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 17, 1989, 60 days after receiving the submission on September 18, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.
| 510(k) Number | K895607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 18, 1989 |
| Decision Date | November 17, 1989 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3320 |