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FDA 510(k)

Zavation VariSync Plate System and VariSync Spacer System

K-Number: K221049 · 2022-08-12

ApplicantZavation Medical Products, LLC
Decision Date2022-08-12
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation VariSync Plate System and VariSync Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K221049. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zavation VariSync Plate System and VariSync Spacer System?

Zavation VariSync Plate System and VariSync Spacer System is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K221049.

When did Zavation VariSync Plate System and VariSync Spacer System receive FDA 510(k) clearance?

Zavation VariSync Plate System and VariSync Spacer System received FDA 510(k) clearance on 2022-08-12, under 510(k) number K221049.

Who is the listed applicant for Zavation VariSync Plate System and VariSync Spacer System?

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

What is the FDA product code for Zavation VariSync Plate System and VariSync Spacer System?

The FDA product code for Zavation VariSync Plate System and VariSync Spacer System is OVE.

Other records listing Zavation Medical Products, LLC as applicant

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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