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510(k) K080426

MAESTRO WRIST FRACTURE IMPLANT by Biomet Manufacturing Corp — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2008
Date Received
February 20, 2008
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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