Benefix Interspinous Fixation System— 510(k) K143631

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.

Clearance details

Applicant: U&I Corporation
Product code: Code PEK
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.