C.A. Medical Interbody Fusion System— 510(k) K254130

Name: FDA 510(k) clearance K254130
Creator: U.S. Food and Drug Administration
Published: 2026-07-08

Substantially Equivalent

C.A. Medical, LLC

FDA 510(k) clearance K254130 for C.A. Medical Interbody Fusion System, Substantially Equivalent on 2026-07-08. Applicant: C.A. Medical, LLC. Device class: 2.

Summary

C.A. Medical's Interbody Fusion System is filed under ODP, cervical intervertebral fusion devices with bone graft. The name is generic, and the record doesn't give 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 Special 510(k).

C.A. Medical filed from Southlake, Texas. Review took 198 calendar days (December 22, 2025 to July 8, 2026).

Clearance details

Applicant: C.A. Medical, LLC
Product code: Product code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-12-22
Decision date: 2026-07-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Southlake, TX, US

Download summary PDF View on FDA.gov ↗

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K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K260840 — BluEX Cervical Expandable Cage System2026-05-16

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.