AILERON INTERSPINOUS FIXATION SYSTEM— 510(k) K140236

Name: FDA 510(k) clearance K140236
Creator: U.S. Food and Drug Administration
Published: 2014-10-20

Substantially Equivalent

Life Spine, Inc.

FDA 510(k) clearance K140236 for AILERON INTERSPINOUS FIXATION SYSTEM, Substantially Equivalent on 2014-10-20. Applicant: Life Spine, Inc.. Device class: 2.

Clearance details

Applicant: Life Spine, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-01-30
Decision date: 2014-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

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