SPINAL USA CEMENT RESTRICTOR SYSTEM— 510(k) K060132

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K060132 for SPINAL USA CEMENT RESTRICTOR SYSTEM, Substantially Equivalent on 2006-03-16. Applicant: Spinal USA. Device class: 2.

Clearance details

Applicant: Spinal USA
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2006-01-18
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brandon, MS, 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.