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510(k) K162153

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System by Ascension Orthopedics — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2017
Date Received
August 2, 2016
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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  • K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM (February 13, 2013)
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