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510(k) K103248

INTEGRITY SPINAL CARE SYSTEM by Integra Life Sciences — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2011
Date Received
November 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

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