SPECTRUM SPINE SPINOUS PROCESS DEVICE— 510(k) K130066

Name: FDA 510(k) clearance K130066
Creator: U.S. Food and Drug Administration
Published: 2013-11-12

Substantially Equivalent

Spectrum Spine IP Holdings, LLC

FDA 510(k) clearance K130066 for SPECTRUM SPINE SPINOUS PROCESS DEVICE, Substantially Equivalent on 2013-11-12. Applicant: Spectrum Spine IP Holdings, LLC. Device class: 2.

Clearance details

Applicant: Spectrum Spine IP Holdings, LLC
Product code: Product code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2013-01-10
Decision date: 2013-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apple Valley, MN, US

Download summary PDF View on FDA.gov ↗

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