510(k) K931265

FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND by Ferguson Medical — Product Code JWI

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