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FDA 510(k)

UniVy OsteoVy Cervical IBF System

K-Number: K221162 · 2022-11-04

ApplicantVy Spine, LLC
Decision Date2022-11-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UniVy OsteoVy Cervical IBF System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2022-11-04 under approval number K221162. 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 Cervical IBF System?

UniVy OsteoVy Cervical IBF System is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Vy Spine, LLC. The 510(k) number is K221162.

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

UniVy OsteoVy Cervical IBF System received FDA 510(k) clearance on 2022-11-04, under approval number K221162.

What company makes UniVy OsteoVy Cervical IBF System?

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

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

The FDA product code for UniVy OsteoVy Cervical IBF System is ODP.

Related Clinical Trials

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Other Devices by Vy Spine, LLC

K213219Vy Spine™ VyWasher™ Buttress System K212715Vy Spine ClariVy Cervical IBF System K213394Vy Spine™ VySpan™ PCT System K221572VyPlate Anterior Cervical Plate System K213750VyLink™ Spinal Screw System K212930LumiVy Lumbar IBF System

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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.

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