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510(k) K031203

BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST by DePuy Orthopaedics, Inc. — Product Code JWJ

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

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