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510(k) K141949

CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM by Aap Implantate AG — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2014
Date Received
July 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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