Xenco Medical CancelleX Cervical Interbody System— 510(k) K243673

Name: FDA 510(k) clearance K243673
Creator: U.S. Food and Drug Administration
Published: 2025-01-29

Substantially Equivalent

Xenco Medical, LLC

FDA 510(k) clearance K243673 for Xenco Medical CancelleX Cervical Interbody System, Substantially Equivalent on 2025-01-29. Applicant: Xenco Medical, LLC. Device class: 2.

Clearance details

Applicant: Xenco Medical, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-11-27
Decision date: 2025-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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

More clearances from Xenco Medical, LLC

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K223059 — Xenco Medical InterAlign Cervical Interbody System2023-06-07
K213456 — Xenco Medical Multilevel CerviKit2021-12-21
K191074 — Sorrento Bone Graft Substitute2019-09-27
K190364 — CancelleX Porous Titanium Lumbar Interbody Device2019-04-18
K173933 — Sorrento Bioglass Bone Graft Substitute2018-09-13

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.