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510(k) K133691

EXTRIMILOCK ANKLE PLATING SYSTEM by Osteomed LP — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2014
Date Received
December 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K161041 — OsteoMed ExtremiLOCK Wrist Plating System (May 19, 2016)
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