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FDA 510(k)

OPTIX H2 Patient Specific Instrument System

K-Number: K230462 · 2023-07-17

ApplicantVilex, LLC
Decision Date2023-07-17
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTIX H2 Patient Specific Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230462. 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 OPTIX H2 Patient Specific Instrument System?

OPTIX H2 Patient Specific Instrument System is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Vilex, LLC. The 510(k) number is K230462.

When did OPTIX H2 Patient Specific Instrument System receive FDA 510(k) clearance?

OPTIX H2 Patient Specific Instrument System received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230462.

Who is the listed applicant for OPTIX H2 Patient Specific Instrument System?

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

What is the FDA product code for OPTIX H2 Patient Specific Instrument System?

The FDA product code for OPTIX H2 Patient Specific Instrument System is HSN.

Other records listing Vilex, LLC as applicant

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.

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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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