K020291 is an FDA 510(k) clearance for the EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER. 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 February 27, 2002, 30 days after receiving the submission on January 28, 2002.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K020291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2002 |
| Decision Date | February 27, 2002 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |