FDA 510(k)

Battalion Universal Spacer System

K-Number: K160958 · 2016-09-08

Decision Date2016-09-08

Product CodePHM

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Battalion Universal Spacer System is a medical device manufactured by Alphatec Spine. It received FDA 510(k) clearance on 2016-09-08 under approval 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. It is manufactured by Alphatec Spine. The 510(k) number is K160958.

When was Battalion Universal Spacer System approved by the FDA?

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

What company makes Battalion Universal Spacer System?

Battalion Universal Spacer System is manufactured by Alphatec Spine.

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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Other Devices by Alphatec Spine

K191185Solanas® Posterior OCT Fixation System K222028IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System K240951Invictus Robotic Navigation Instruments K251575IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer

Related Devices (Code: PHM)

K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.