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FDA 510(k)

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System

K-Number: K233509 · 2024-04-10

ApplicantZavation Medical Products, LLC
Decision Date2024-04-10
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2024-04-10 under approval number K233509. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System?

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System is a medical device that received FDA 510(k) clearance on 2024-04-10. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K233509.

When was Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System approved by the FDA?

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System received FDA 510(k) clearance on 2024-04-10, under approval number K233509.

What company makes Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System?

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System?

The FDA product code for Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System is MAX.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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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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