MODIFICATION TO: DSS STABILIZATION SYSTEM— 510(k) K091944

Name: FDA 510(k) clearance K091944
Creator: U.S. Food and Drug Administration
Published: 2009-08-03

Substantially Equivalent

Paradigm Spine, LLC

FDA 510(k) clearance K091944 for MODIFICATION TO: DSS STABILIZATION SYSTEM, Substantially Equivalent on 2009-08-03. Applicant: Paradigm Spine, LLC. Device class: 2.

Clearance details

Applicant: Paradigm Spine, LLC
Product code: Code NQP
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2009-06-30
Decision date: 2009-08-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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