K010243 is an FDA 510(k) clearance for the TRI-FIT FEMORAL STEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code LWJ).
Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on February 15, 2001, 21 days after receiving the submission on January 25, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K010243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2001 |
| Decision Date | February 15, 2001 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LWJ - Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |