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FDA 510(k)

Vy Spine ClariVy Cervical IBF System

K-Number: K212715 · 2021-12-20

ApplicantVy Spine, LLC
Decision Date2021-12-20
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vy Spine ClariVy Cervical IBF System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2021-12-20 under approval number K212715. 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 Vy Spine ClariVy Cervical IBF System?

Vy Spine ClariVy Cervical IBF System is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Vy Spine, LLC. The 510(k) number is K212715.

When was Vy Spine ClariVy Cervical IBF System approved by the FDA?

Vy Spine ClariVy Cervical IBF System received FDA 510(k) clearance on 2021-12-20, under approval number K212715.

What company makes Vy Spine ClariVy Cervical IBF System?

Vy Spine ClariVy Cervical IBF System is manufactured by Vy Spine, LLC.

What is the FDA product code for Vy Spine ClariVy Cervical IBF System?

The FDA product code for Vy Spine ClariVy Cervical IBF System is ODP.

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Other Devices by Vy Spine, LLC

K213219Vy Spine™ VyWasher™ Buttress System K213394Vy Spine™ VySpan™ PCT System K221162UniVy OsteoVy Cervical IBF 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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