INTEGRITY SPINAL CARE SYSTEM 3.0— 510(k) K130249

Name: FDA 510(k) clearance K130249
Creator: U.S. Food and Drug Administration
Published: 2014-02-06

Substantially Equivalent

Integrity Life Sciences

FDA 510(k) clearance K130249 for INTEGRITY SPINAL CARE SYSTEM 3.0, Substantially Equivalent on 2014-02-06. Applicant: Integrity Life Sciences. Device class: 2.

Clearance details

Applicant: Integrity Life Sciences
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2013-02-01
Decision date: 2014-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, 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.