VIA SPINOUS PROCESS FIXATION SYSTEM— 510(k) K142213

Name: FDA 510(k) clearance K142213
Creator: U.S. Food and Drug Administration
Published: 2014-09-10

Substantially Equivalent

Spineology, Inc.

FDA 510(k) clearance K142213 for VIA SPINOUS PROCESS FIXATION SYSTEM, Substantially Equivalent on 2014-09-10. Applicant: Spineology, Inc.. Device class: 2.

Clearance details

Applicant: Spineology, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-08-12
Decision date: 2014-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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