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510(k) K042032

MAESTRO TOTAL WRIST by Biomet, Inc. — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2004
Date Received
July 28, 2004
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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Other clearances for product code JWJ

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  • K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (March 24, 2014)
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  • K031203 — BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (July 14, 2003)
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