510(k) K931131

THE RICHARDS WRIST by Smith & Nephew Richards, Inc. — Product Code JWJ

K931131 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "THE RICHARDS WRIST". The FDA issued a decision of SN on August 19, 1994. 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. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 19, 1994
Date Received
March 5, 1993
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