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510(k) K182878

Integra Salto Total Ankle System by Ascension Orthopedics — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2018
Date Received
October 15, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

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