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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 the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2022-11-04 under 510(k) 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. The listed applicant is Vy Spine, LLC. The 510(k) number is K221162.

When did UniVy OsteoVy Cervical IBF System receive FDA 510(k) clearance?

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

Who is the listed applicant for UniVy OsteoVy Cervical IBF System?

The FDA 510(k) record lists Vy Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Vy Spine, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260697VyPlate™ Anterior Cervical Plate SystemK253432DiversiVy™ Facet Screw SystemK253158VyBrate™ VBR SystemK241783FortiVy™ OsteoVy™ Lumbar IBFK242784Vy Spine™ VyLam™ Laminoplasty SystemK233807LumiVy™ Lumbar IBF System

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Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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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