K173880 is an FDA 510(k) clearance for the Corin TriFit CF Hip Stem. This device is classified as a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II - Special Controls, product code MEH).
Submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on April 11, 2018, 111 days after receiving the submission on December 21, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K173880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2017 |
| Decision Date | April 11, 2018 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |