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FDA 510(k)

IdentiTi Cervical Standalone Interbody System

K-Number: K202812 · 2020-12-18

ApplicantAlphatec Spine, Inc.
Decision Date2020-12-18
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IdentiTi Cervical Standalone Interbody System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2020-12-18 under approval number K202812. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IdentiTi Cervical Standalone Interbody System?

IdentiTi Cervical Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K202812.

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

IdentiTi Cervical Standalone Interbody System received FDA 510(k) clearance on 2020-12-18, under approval number K202812.

What company makes IdentiTi Cervical Standalone Interbody System?

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

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

The FDA product code for IdentiTi Cervical Standalone Interbody System is OVE.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife 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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