K010310 is an FDA 510(k) clearance for the MODIFICATION TO TRIDENT ALL POLY CUP. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 20, 2001, 47 days after receiving the submission on February 1, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K010310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2001 |
| Decision Date | March 20, 2001 |
| Days to Decision | 47 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 |