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510(k) K131135

BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS by Biomet Manufacturing Corp — Product Code MBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2014
Date Received
April 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Antibiotic
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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