CoFix System— 510(k) K201704

Substantially Equivalent

Paradigm Spine GmbH

FDA 510(k) clearance K201704 for CoFix System, Substantially Equivalent on 2020-08-04. Applicant: Paradigm Spine GmbH. Device class: 2.

Clearance details

Applicant: Paradigm Spine GmbH
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2020-06-22
Decision date: 2020-08-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.