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510(k) K023063

COMPREHENSIVE HUMERAL FRACTURE SYSTEM by Biomet Orthopedics, Inc. — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2002
Date Received
September 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

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