Flex-Z Cervical Cage— 510(k) K252432

Name: FDA 510(k) clearance K252432
Creator: U.S. Food and Drug Administration
Published: 2026-03-25

Substantially Equivalent

Spinepoint, LLC

FDA 510(k) clearance K252432 for Flex-Z Cervical Cage, Substantially Equivalent on 2026-03-25. Applicant: Spinepoint, LLC. Device class: 2.

Summary

Spinepoint's Flex-Z Cervical Cage is filed under ODP, cervical intervertebral fusion devices with bone graft. The record doesn't list sizes or materials.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Spinepoint filed from Reno, Nevada. Review took 236 calendar days (August 1, 2025 to March 25, 2026).

Clearance details

Applicant: Spinepoint, LLC
Product code: Product code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-08-01
Decision date: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.