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510(k) K151459

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2015
Date Received
June 1, 2015
Clearance Type
Traditional
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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  • K241482 — Kinos Total Ankle System (July 22, 2024)
  • K240259 — APEX 3D Total Ankle Replacement System (June 24, 2024)
  • K240591 — restor3d Kinos Axiom Total Ankle System (April 29, 2024)
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