DSS STABILIZATION SYSTEM— 510(k) K080963

Substantially Equivalent

Paradigm Spine

FDA 510(k) clearance K080963 for DSS STABILIZATION SYSTEM, Substantially Equivalent on 2008-05-02. Applicant: Paradigm Spine. Device class: 2.

Clearance details

Applicant: Paradigm Spine
Product code: Code NQP
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-04-04
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Paradigm Spine

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Data sourced from openFDA. This site is unofficial and independent of the FDA.