K030122 is an FDA 510(k) clearance for the DEPUY SUMMIT BASIC PRESS-FIT HIP STEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code LWJ).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 5, 2003, 22 days after receiving the submission on January 14, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K030122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2003 |
| Decision Date | February 05, 2003 |
| Days to Decision | 22 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 |