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FDA 510(k)

ATEC Posterior Navigated Disc Prep Instruments

K-Number: K232345 · 2023-11-02

ApplicantAlphatec Spine, Inc.
Decision Date2023-11-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ATEC Posterior Navigated Disc Prep Instruments is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-11-02 under approval number K232345. 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 Posterior Navigated Disc Prep Instruments?

ATEC Posterior Navigated Disc Prep Instruments is a medical device that received FDA 510(k) clearance on 2023-11-02. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K232345.

When was ATEC Posterior Navigated Disc Prep Instruments approved by the FDA?

ATEC Posterior Navigated Disc Prep Instruments received FDA 510(k) clearance on 2023-11-02, under approval number K232345.

What company makes ATEC Posterior Navigated Disc Prep Instruments?

ATEC Posterior Navigated Disc Prep Instruments is manufactured by Alphatec Spine, Inc..

What is the FDA product code for ATEC Posterior Navigated Disc Prep Instruments?

The FDA product code for ATEC Posterior Navigated Disc Prep Instruments is OLO.

Related Clinical Trials

NCT07536139 COMPARATIVE EFFICACY OF ELECTROMAGNETIC FIELD THERAPY AND TIBIAL NERVE STIMULATION IN URGE URINARY INCONTINENCE NOT_YET_RECRUITING

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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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