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FDA 510(k)

Battalion Universal Spacer System

K-Number: K160958 · 2016-09-08

ApplicantAlphatec Spine
Decision Date2016-09-08
Product CodePHM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Battalion Universal Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K160958. 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 Battalion Universal Spacer System?

Battalion Universal Spacer System is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Alphatec Spine. The 510(k) number is K160958.

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

Battalion Universal Spacer System received FDA 510(k) clearance on 2016-09-08, under 510(k) number K160958.

Who is the listed applicant for Battalion Universal Spacer System?

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

What is the FDA product code for Battalion Universal Spacer System?

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

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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.

K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.

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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