SPINE WORKS COLLAR— 510(k) K003662

Substantially Equivalent

Spine Works

FDA 510(k) clearance K003662 for SPINE WORKS COLLAR, Substantially Equivalent on 2001-07-09. Applicant: Spine Works. Device class: 2.

Clearance details

Applicant: Spine Works
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 2000-11-28
Decision date: 2001-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Traverse City, MI, 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.