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FDA 510(k)

OMNI Skirted Heads

K-Number: K152919 · 2016-03-10

ApplicantOmni Life Science, Inc.
Decision Date2016-03-10
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNI Skirted Heads is a medical device manufactured by Omni Life Science, Inc.. It received FDA 510(k) clearance on 2016-03-10 under approval number K152919. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI Skirted Heads?

OMNI Skirted Heads is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Omni Life Science, Inc.. The 510(k) number is K152919.

When was OMNI Skirted Heads approved by the FDA?

OMNI Skirted Heads received FDA 510(k) clearance on 2016-03-10, under approval number K152919.

What company makes OMNI Skirted Heads?

OMNI Skirted Heads is manufactured by Omni Life Science, Inc..

What is the FDA product code for OMNI Skirted Heads?

The FDA product code for OMNI Skirted Heads is LZO.

Other Devices by Omni Life Science, Inc.

K191765OMNI TiN Coated Apex Knee™ System

Related Devices (Code: LZO)

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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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