FDA.report

510(k) K230717

Device
Exactech® Vantage® Total Ankle System
Applicant
Exactech, Inc.
510(k) number
K230717
Product code
HSN
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-12
Date received
2023-03-15
Regulation
888.3110
Classification name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Pedro Ravelo
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
10885862656865VantageExactech, Inc.2026-03-10
10885862656902VantageExactech, Inc.2026-03-10
10885862656926VantageExactech, Inc.2026-03-10
10885862656872VantageExactech, Inc.2026-03-10
10885862656858VantageExactech, Inc.2026-03-10
10885862656841VantageExactech, Inc.2026-03-10
10885862656933VantageExactech, Inc.2026-03-10
10885862656919VantageExactech, Inc.2026-03-10
10885862656889VantageExactech, Inc.2026-03-10
10885862656834VantageExactech, Inc.2026-03-10
10885862656896VantageExactech, Inc.2026-03-10
10885862656940VantageExactech, Inc.2026-03-10
10885862657190VantageExactech, Inc.2025-05-12
10885862657114VantageExactech, Inc.2025-05-12
10885862657169VantageExactech, Inc.2025-05-12
10885862657206VantageExactech, Inc.2025-05-12
10885862657107VantageExactech, Inc.2025-05-12
10885862657183VantageExactech, Inc.2025-05-12
10885862657145VantageExactech, Inc.2025-05-12
10885862657121VantageExactech, Inc.2025-05-12
10885862657176VantageExactech, Inc.2025-05-12
10885862657152VantageExactech, Inc.2025-05-12
10885862657138VantageExactech, Inc.2025-05-12
10885862630506VantageExactech, Inc.2024-08-28
10885862630513VantageExactech, Inc.2024-08-28
10885862628831VantageExactech, Inc.2024-08-28
10885862628770VantageExactech, Inc.2024-08-28
10885862628763VantageExactech, Inc.2024-08-28
10885862628756VantageExactech, Inc.2024-08-28
10885862628749VantageExactech, Inc.2024-08-28

Other 510(k) Records For Product Code HSN

510(k)DeviceApplicantDecision date
K252454Kinos Total Ankle SystemRestor3D2025-09-03
K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)2025-06-20
K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2025-05-01
K240475Hintermann Series H2 Total Ankle SystemVilex, LLC2024-12-02
K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)2024-11-01
K242868Kinos Total Ankle SystemRestor3D2024-10-18
K241482Kinos Total Ankle SystemRestor3D2024-07-22
K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2024-06-24
K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.2024-04-29
K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas2024-04-23
K232595Kinos Axiom Total Ankle SystemRestor3D2023-11-28
K232002Vantage® Total Ankle SystemExactech, Inc.2023-09-11
K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC2023-07-17
K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas2023-04-06
K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2023-01-27