INTEGRITY SPINAL CARE SYSTEM— 510(k) K103248

Name: FDA 510(k) clearance K103248
Creator: U.S. Food and Drug Administration
Published: 2011-04-05

Substantially Equivalent

Integra Life Sciences

FDA 510(k) clearance K103248 for INTEGRITY SPINAL CARE SYSTEM, Substantially Equivalent on 2011-04-05. Applicant: Integra Life Sciences. Device class: 2.

Clearance details

Applicant: Integra Life Sciences
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2010-11-03
Decision date: 2011-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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