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510(k) K131445

OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM by Osteomed LP — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2013
Date Received
May 20, 2013
Clearance Type
Special
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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