510(k) K031203
K031203 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST". The FDA issued a decision of Substantially Equivalent on July 14, 2003. The device falls under product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2003
- Date Received
- April 16, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- Device Class
- Class II
- Regulation Number
- 888.3800
- Review Panel
- OR
- Submission Type