K003649 is an FDA 510(k) clearance for the TRITON HIP SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code LWJ).
Submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on February 23, 2001, 88 days after receiving the submission on November 27, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K003649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2000 |
| Decision Date | February 23, 2001 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LWJ — Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |