SPINA SYSTEM— 510(k) K033231

Substantially Equivalent

North American Medical Corp (Nam)

FDA 510(k) clearance K033231 for SPINA SYSTEM, Substantially Equivalent on 2005-09-09. Applicant: North American Medical Corp (Nam). Device class: 2.

Clearance details

Applicant: North American Medical Corp (Nam)
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2003-10-06
Decision date: 2005-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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