AXXION LIGHT GUIDE— 510(k) K082992

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K082992 for AXXION LIGHT GUIDE, Substantially Equivalent on 2009-02-18. Applicant: Spinal Elements, Inc.. Device class: 2.

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2008-10-07
Decision date: 2009-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.