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510(k) K210390

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2021
Date Received
February 9, 2021
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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