ResCUBE Ligament Fixation System— 510(k) K181799

Name: FDA 510(k) clearance K181799
Creator: U.S. Food and Drug Administration
Published: 2018-08-29

Substantially Equivalent

Cousin Biotech Sas

FDA 510(k) clearance K181799 for ResCUBE Ligament Fixation System, Substantially Equivalent on 2018-08-29. Applicant: Cousin Biotech Sas. Device class: 2.

Clearance details

Applicant: Cousin Biotech Sas
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2018-07-05
Decision date: 2018-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wervicq-Sud, FR

Download summary PDF View on FDA.gov ↗

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