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510(k) K153087

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved by Ivy Sports Medicine, LLC — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2016
Date Received
October 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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