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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 the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-11-02 under 510(k) 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. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232345.

When did ATEC Posterior Navigated Disc Prep Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for ATEC Posterior Navigated Disc Prep Instruments?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: 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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