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510(k) K250641

APEX 3D Total Ankle Replacement System by Paragon 28, Inc. — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2025
Date Received
March 4, 2025
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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Other clearances for product code HSN

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