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510(k) K240259

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2024
Date Received
January 31, 2024
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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  • K240475 — Hintermann Series H2 Total Ankle System (December 2, 2024)
  • K241999 — Prophecy Surgical Planning System (November 1, 2024)
  • K242868 — Kinos Total Ankle System (October 18, 2024)
  • K241482 — Kinos Total Ankle System (July 22, 2024)
  • K240591 — restor3d Kinos Axiom Total Ankle System (April 29, 2024)
  • K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System (April 23, 2024)
  • K232595 — Kinos Axiom Total Ankle System (November 28, 2023)