Benefix Interspinous Fixation System— 510(k) K143631

Name: FDA 510(k) clearance K143631
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Substantially Equivalent

U&I Corporation

FDA 510(k) clearance K143631 for Benefix Interspinous Fixation System, Substantially Equivalent on 2015-09-03. Applicant: U&I Corporation. Device class: 2.

Clearance details

Applicant: U&I Corporation
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2014-12-22
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijeongbu-Si, KR

Download summary PDF View on FDA.gov ↗

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