SUREFIX INTERSPINOUS FUSION SYSTEM— 510(k) K124014

Name: FDA 510(k) clearance K124014
Creator: U.S. Food and Drug Administration
Published: 2013-08-09

Substantially Equivalent

Jg Spine, LLC

FDA 510(k) clearance K124014 for SUREFIX INTERSPINOUS FUSION SYSTEM, Substantially Equivalent on 2013-08-09. Applicant: Jg Spine, LLC. Device class: 2.

Clearance details

Applicant: Jg Spine, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2012-12-27
Decision date: 2013-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waxhaw, NC, US

Download summary PDF View on FDA.gov ↗

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