510(k) K931265
K931265 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND". The FDA issued a decision of SN on May 22, 1995. The device falls under product code JWI (Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Ferguson Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- May 22, 1995
- Date Received
- March 8, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
- Device Class
- Class II
- Regulation Number
- 888.3800
- Review Panel
- OR
- Submission Type