FDA 510(k)

ClariVy Cervical IBF System

K-Number: K231836 · 2023-10-30

Decision Date2023-10-30

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ClariVy Cervical IBF System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2023-10-30 under approval number K231836. 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 ClariVy Cervical IBF System?

ClariVy Cervical IBF System is a medical device that received FDA 510(k) clearance on 2023-10-30. It is manufactured by Vy Spine, LLC. The 510(k) number is K231836.

When was ClariVy Cervical IBF System approved by the FDA?

ClariVy Cervical IBF System received FDA 510(k) clearance on 2023-10-30, under approval number K231836.

What company makes ClariVy Cervical IBF System?

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

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

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

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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 K221162UniVy OsteoVy Cervical IBF System K221572VyPlate Anterior Cervical Plate System K213750VyLink Spinal Screw 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.