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510(k) K232002

Vantage® Total Ankle System by Exactech, Inc. — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2023
Date Received
July 5, 2023
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

Other clearances by Exactech, Inc.

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  • K240393 — Exactech® TRULIANT® Knee System (October 3, 2024)
  • K233482 — Equinoxe® Central Screw Baseplate System (July 18, 2024)
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  • K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (September 25, 2023)
  • K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (September 14, 2023)
  • K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (July 17, 2023)

Other clearances for product code HSN

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  • K250641 — APEX 3D Total Ankle Replacement System (May 1, 2025)
  • 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)
  • K240259 — APEX 3D Total Ankle Replacement System (June 24, 2024)
  • K240591 — restor3d Kinos Axiom Total Ankle System (April 29, 2024)
  • K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System (April 23, 2024)