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FDA 510(k)

ATEC Lateral Navigation Instruments

K-Number: K223765 · 2023-03-23

ApplicantAlphatec Spine, Inc.
Decision Date2023-03-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ATEC Lateral Navigation Instruments is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-03-23 under approval number K223765. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATEC Lateral Navigation Instruments?

ATEC Lateral Navigation Instruments is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K223765.

When was ATEC Lateral Navigation Instruments approved by the FDA?

ATEC Lateral Navigation Instruments received FDA 510(k) clearance on 2023-03-23, under approval number K223765.

What company makes ATEC Lateral Navigation Instruments?

ATEC Lateral Navigation Instruments is manufactured by Alphatec Spine, Inc..

What is the FDA product code for ATEC Lateral Navigation Instruments?

The FDA product code for ATEC Lateral Navigation Instruments is OLO.

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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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