FDA 510(k)

Flex-Z Cervical Cage

K-Number: K252432 · 2026-03-25

Decision Date2026-03-25

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Flex-Z Cervical Cage is a medical device manufactured by Spinepoint, LLC. It received FDA 510(k) clearance on 2026-03-25 under approval number K252432. 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 Flex-Z Cervical Cage?

Flex-Z Cervical Cage is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Spinepoint, LLC. The 510(k) number is K252432.

When was Flex-Z Cervical Cage approved by the FDA?

Flex-Z Cervical Cage received FDA 510(k) clearance on 2026-03-25, under approval number K252432.

What company makes Flex-Z Cervical Cage?

Flex-Z Cervical Cage is manufactured by Spinepoint, LLC.

What is the FDA product code for Flex-Z Cervical Cage?

The FDA product code for Flex-Z Cervical Cage is ODP.

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.