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FDA 510(k)

IdentiTi ALIF Standalone Interbody System

K-Number: K203742 · 2021-04-09

ApplicantAlphatec Spine, Inc.
Decision Date2021-04-09
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IdentiTi ALIF Standalone Interbody System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2021-04-09 under approval number K203742. 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 Standalone Interbody System?

IdentiTi ALIF Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2021-04-09. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K203742.

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

IdentiTi ALIF Standalone Interbody System received FDA 510(k) clearance on 2021-04-09, under approval number K203742.

What company makes IdentiTi ALIF Standalone Interbody System?

IdentiTi ALIF Standalone Interbody System is manufactured by Alphatec Spine, Inc..

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

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

Related Clinical Trials

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ 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

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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