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FDA 510(k)

ATEC Universal Spacer System

K-Number: K180480 · 2018-05-31

ApplicantAlphatec Spine, Inc.
Decision Date2018-05-31
Product CodePHM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATEC Universal Spacer System 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 2018-05-31 under 510(k) number K180480. The device is classified under product code PHM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATEC Universal Spacer System?

ATEC Universal Spacer System is a medical device that received FDA 510(k) clearance on 2018-05-31. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K180480.

When did ATEC Universal Spacer System receive FDA 510(k) clearance?

ATEC Universal Spacer System received FDA 510(k) clearance on 2018-05-31, under 510(k) number K180480.

Who is the listed applicant for ATEC Universal Spacer System?

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 Universal Spacer System?

The FDA product code for ATEC Universal Spacer System is PHM.

Other records listing Alphatec Spine, Inc. as applicant

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Related Devices (Code: PHM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160958Battalion Universal Spacer SystemAlphatec Spine

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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