FDA 510(k)

CUVIS-spine

K-Number: K201569 · 2021-05-19

Decision Date2021-05-19

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CUVIS-spine is the device name listed in this FDA 510(k) record. The listed applicant is Curexo, Inc.. It received FDA 510(k) clearance on 2021-05-19 under 510(k) number K201569. 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 2021-05-19. The listed applicant is Curexo, Inc.. The 510(k) number is K201569.

When did CUVIS-spine receive FDA 510(k) clearance?

CUVIS-spine received FDA 510(k) clearance on 2021-05-19, under 510(k) number K201569.

Who is the listed applicant for CUVIS-spine?

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

What is the FDA product code for CUVIS-spine?

The FDA product code for CUVIS-spine is OLO.

Other records listing Curexo, Inc. 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.

K252037CUVIS-joint (CJ150)K223558CUVIS-spine K222698CUVIS-spine

Related Devices (Code: OLO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.