MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK— 510(k) K172212

Name: FDA 510(k) clearance K172212
Creator: U.S. Food and Drug Administration
Published: 2018-01-09

Substantially Equivalent

Ctl Medical Corporation

FDA 510(k) clearance K172212 for MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK, Substantially Equivalent on 2018-01-09. Applicant: Ctl Medical Corporation. Device class: 2.

Clearance details

Applicant: Ctl Medical Corporation
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2017-07-24
Decision date: 2018-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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 Ctl Medical Corporation

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K233947 — KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System2024-10-10
K231715 — MONDRIAN Anterior Lumbar Plate System2024-01-26
K231359 — RODIN Expandable Lumbar Cage System2023-06-09
K220513 — NITRO Interbody Fusion Cage System Family2023-04-25
K220334 — MONET Anterior Cervical Plate System2022-11-09

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.