FDA 510(k)

UniVy OsteoVy-Ti Cervical IBF System

K-Number: K223513 · 2023-04-18

Decision Date2023-04-18

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UniVy OsteoVy-Ti Cervical IBF System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2023-04-18 under approval number K223513. 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 UniVy OsteoVy-Ti Cervical IBF System?

UniVy OsteoVy-Ti Cervical IBF System is a medical device that received FDA 510(k) clearance on 2023-04-18. It is manufactured by Vy Spine, LLC. The 510(k) number is K223513.

When was UniVy OsteoVy-Ti Cervical IBF System approved by the FDA?

UniVy OsteoVy-Ti Cervical IBF System received FDA 510(k) clearance on 2023-04-18, under approval number K223513.

What company makes UniVy OsteoVy-Ti Cervical IBF System?

UniVy OsteoVy-Ti Cervical IBF System is manufactured by Vy Spine, LLC.

What is the FDA product code for UniVy OsteoVy-Ti Cervical IBF System?

The FDA product code for UniVy OsteoVy-Ti Cervical IBF 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Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING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 Vy Spine, LLC

K213219Vy Spine VyWasher Buttress System K212715Vy Spine ClariVy Cervical IBF System K213394Vy Spine VySpan PCT System K221162UniVy OsteoVy Cervical IBF System K221572VyPlate Anterior Cervical Plate System K213750VyLink Spinal Screw System

View all 21 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.