FDA 510(k)

IdentiTi ALIF Interbody Systems

K-Number: K232097 · 2023-09-25

Decision Date2023-09-25

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

IdentiTi ALIF Interbody Systems is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-09-25 under approval number K232097. 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 ALIF Interbody Systems?

IdentiTi ALIF Interbody Systems is a medical device that received FDA 510(k) clearance on 2023-09-25. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K232097.

When was IdentiTi ALIF Interbody Systems approved by the FDA?

IdentiTi ALIF Interbody Systems received FDA 510(k) clearance on 2023-09-25, under approval number K232097.

What company makes IdentiTi ALIF Interbody Systems?

IdentiTi ALIF Interbody Systems is manufactured by Alphatec Spine, Inc..

What is the FDA product code for IdentiTi ALIF Interbody Systems?

The FDA product code for IdentiTi ALIF Interbody Systems is OVD.

Other Devices by Alphatec Spine, Inc.

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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.