Cervical Interbody Fusion System— 510(k) K160324

Name: FDA 510(k) clearance K160324
Creator: U.S. Food and Drug Administration
Published: 2016-05-05

Substantially Equivalent

Evolution Spine, LLC

FDA 510(k) clearance K160324 for Cervical Interbody Fusion System, Substantially Equivalent on 2016-05-05. Applicant: Evolution Spine, LLC. Device class: 2.

Clearance details

Applicant: Evolution Spine, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2016-02-05
Decision date: 2016-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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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

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K180755 — Vail ALIF Buttress Plate System2018-07-06
K173375 — Anterior Cervical Plate System2017-12-21
K160663 — Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)2016-11-16

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.