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FDA 510(k)

OMNI TiN Coated Apex Knee™ System

K-Number: K191765 · 2019-09-25

ApplicantOmni Life Science, Inc.
Decision Date2019-09-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNI TiN Coated Apex Knee™ System is a medical device manufactured by Omni Life Science, Inc.. It received FDA 510(k) clearance on 2019-09-25 under approval number K191765. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI TiN Coated Apex Knee™ System?

OMNI TiN Coated Apex Knee™ System is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Omni Life Science, Inc.. The 510(k) number is K191765.

When was OMNI TiN Coated Apex Knee™ System approved by the FDA?

OMNI TiN Coated Apex Knee™ System received FDA 510(k) clearance on 2019-09-25, under approval number K191765.

What company makes OMNI TiN Coated Apex Knee™ System?

OMNI TiN Coated Apex Knee™ System is manufactured by Omni Life Science, Inc..

What is the FDA product code for OMNI TiN Coated Apex Knee™ System?

The FDA product code for OMNI TiN Coated Apex Knee™ System is JWH.

Related Clinical Trials

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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.

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