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 a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2023-07-17 under approval 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. It is manufactured by Vilex, LLC. The 510(k) number is K230462.
When was OPTIX H2 Patient Specific Instrument System approved by the FDA?
OPTIX H2 Patient Specific Instrument System received FDA 510(k) clearance on 2023-07-17, under approval number K230462.
What company makes OPTIX H2 Patient Specific Instrument System?
OPTIX H2 Patient Specific Instrument System is manufactured by Vilex, LLC.
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.
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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.