Talos-C(HA) Cervical Intervertebral Body Fusion Devices— 510(k) K142345

Name: FDA 510(k) clearance K142345
Creator: U.S. Food and Drug Administration
Published: 2015-02-22

Substantially Equivalent

Meditech Spine, LLC

FDA 510(k) clearance K142345 for Talos-C(HA) Cervical Intervertebral Body Fusion Devices, Substantially Equivalent on 2015-02-22. Applicant: Meditech Spine, LLC. Device class: 2.

Clearance details

Applicant: Meditech Spine, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2014-08-22
Decision date: 2015-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, 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 Meditech Spine, LLC

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K210286 — Cure 2.0 Anterior Cervical Plate (ACP) System2021-03-18
K201506 — Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System2020-09-11
K201136 — Cure Lumbar Plate System2020-05-12
K181543 — Cure OPEL-C Plate System2018-08-31
K180090 — Cure Lumbar Plate System2018-04-23

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.