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510(k) K151387

Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade by Stryker — Product Code HBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2015
Date Received
May 26, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Plate, Cranioplasty
Device Class
Class II
Regulation Number
882.5360
Review Panel
NE
Submission Type

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