coflex-IF— 510(k) K153302

Substantially Equivalent

Paradigm Spine, LLC

FDA 510(k) clearance K153302 for coflex-IF, Substantially Equivalent on 2016-09-08. Applicant: Paradigm Spine, LLC. Device class: 2.

Clearance details

Applicant: Paradigm Spine, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2015-11-13
Decision date: 2016-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Paradigm Spine, LLC

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K093438 — PARADIGM INTERSPINOUS FUSION PLATE2010-10-06
K101083 — DSS STABILIZATION SYSTEM2010-07-02

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