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FDA 510(k)

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System

K-Number: K193067 · 2020-06-08

ApplicantWrightmedicaltechnologyinc
Decision Date2020-06-08
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2020-06-08 under 510(k) number K193067. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is a medical device that received FDA 510(k) clearance on 2020-06-08. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K193067.

When did The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System receive FDA 510(k) clearance?

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System received FDA 510(k) clearance on 2020-06-08, under 510(k) number K193067.

Who is the listed applicant for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

The FDA 510(k) record lists Wrightmedicaltechnologyinc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

The FDA product code for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is HSN.

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Related Devices (Code: HSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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