510(k) K933871
K933871 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "BRIDGE(TM) HIP SYSTEM". The FDA issued a decision of SN on February 23, 1994. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- February 23, 1994
- Date Received
- August 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type