FDA 510(k)

IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System

K-Number: K251575 · 2025-09-03

Decision Date2025-09-03

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System is a medical device manufactured by Alphatec Spine. It received FDA 510(k) clearance on 2025-09-03 under approval number K251575. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System?

IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2025-09-03. It is manufactured by Alphatec Spine. The 510(k) number is K251575.

When was IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System approved by the FDA?

IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System received FDA 510(k) clearance on 2025-09-03, under approval number K251575.

What company makes IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System?

IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System is manufactured by Alphatec Spine.

What is the FDA product code for IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System?

The FDA product code for IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System is OVD.

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Other Devices by Alphatec Spine

K160958Battalion Universal Spacer System 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 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: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.