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510(k) K162544

OsteoMed PINNACLE Driver by Osteomed — Product Code KMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2017
Date Received
September 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Rotary Bone Cutting
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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