Xspan Laminoplasty Fixation System— 510(k) K160114

Name: FDA 510(k) clearance K160114
Creator: U.S. Food and Drug Administration
Published: 2016-03-15

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K160114 for Xspan Laminoplasty Fixation System, Substantially Equivalent on 2016-03-15. Applicant: X-Spine Systems, Inc.. Device class: 2.

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2016-01-19
Decision date: 2016-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

Download summary PDF View on FDA.gov ↗

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