K103518 is an FDA 510(k) clearance for the TRINITY ACETABULAR SYSTEM. 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 March 9, 2011, 99 days after receiving the submission on November 30, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K103518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2010 |
| Decision Date | March 09, 2011 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| 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 |