Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System— 510(k) K201506

Name: FDA 510(k) clearance K201506
Creator: U.S. Food and Drug Administration
Published: 2020-09-11

Substantially Equivalent

Meditech Spine, LLC

FDA 510(k) clearance K201506 for Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System, Substantially Equivalent on 2020-09-11. 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: 2020-06-05
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

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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.