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510(k) K151195

OsteoMed IMF Screw by Osteomed — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2015
Date Received
May 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

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