K933871 is an FDA 510(k) clearance for the BRIDGE(TM) HIP SYSTEM. This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on February 23, 1994, 198 days after receiving the submission on August 9, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K933871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 09, 1993 |
| Decision Date | February 23, 1994 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |