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FDA 510(k)

CUVIS-spine

K-Number: K222698 · 2022-10-07

ApplicantCurexo, Inc.
Decision Date2022-10-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CUVIS-spine is a medical device manufactured by Curexo, Inc.. It received FDA 510(k) clearance on 2022-10-07 under approval number K222698. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUVIS-spine?

CUVIS-spine is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Curexo, Inc.. The 510(k) number is K222698.

When was CUVIS-spine approved by the FDA?

CUVIS-spine received FDA 510(k) clearance on 2022-10-07, under approval number K222698.

What company makes CUVIS-spine?

CUVIS-spine is manufactured by Curexo, Inc..

What is the FDA product code for CUVIS-spine?

The FDA product code for CUVIS-spine is OLO.

Other Devices by Curexo, Inc.

K201569CUVIS-spine K223558CUVIS-spine K252037CUVIS-joint (CJ150)

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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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