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FDA 510(k)

CORNICE Cervical Spacer System

K-Number: K192208 · 2019-10-09

ApplicantLegend Spine Technologies
Decision Date2019-10-09
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORNICE Cervical Spacer System is a medical device manufactured by Legend Spine Technologies. It received FDA 510(k) clearance on 2019-10-09 under approval number K192208. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNICE Cervical Spacer System?

CORNICE Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2019-10-09. It is manufactured by Legend Spine Technologies. The 510(k) number is K192208.

When was CORNICE Cervical Spacer System approved by the FDA?

CORNICE Cervical Spacer System received FDA 510(k) clearance on 2019-10-09, under approval number K192208.

What company makes CORNICE Cervical Spacer System?

CORNICE Cervical Spacer System is manufactured by Legend Spine Technologies.

What is the FDA product code for CORNICE Cervical Spacer System?

The FDA product code for CORNICE Cervical Spacer System is ODP.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED 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Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING

Other Devices by Legend Spine Technologies

K180071STYLO Interbody Fusion Device

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.

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