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510(k) K982398

BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW by Biomet, Inc. — Product Code JDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1998
Date Received
July 10, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Constrained, Cemented
Device Class
Class II
Regulation Number
888.3150
Review Panel
OR
Submission Type

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