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FDA 510(k)

ResCUBE™ Ligament Fixation System

K-Number: K181799 · 2018-08-29

ApplicantCousin Biotech Sas
Decision Date2018-08-29
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ResCUBE™ Ligament Fixation System is a medical device manufactured by Cousin Biotech Sas. It received FDA 510(k) clearance on 2018-08-29 under approval number K181799. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ResCUBE™ Ligament Fixation System?

ResCUBE™ Ligament Fixation System is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Cousin Biotech Sas. The 510(k) number is K181799.

When was ResCUBE™ Ligament Fixation System approved by the FDA?

ResCUBE™ Ligament Fixation System received FDA 510(k) clearance on 2018-08-29, under approval number K181799.

What company makes ResCUBE™ Ligament Fixation System?

ResCUBE™ Ligament Fixation System is manufactured by Cousin Biotech Sas.

What is the FDA product code for ResCUBE™ Ligament Fixation System?

The FDA product code for ResCUBE™ Ligament Fixation System is OWI.

Related Clinical Trials

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Other Devices by Cousin Biotech Sas

K172206NAJA™ Ligament Correction System K181086Cortical Fixation Systems

Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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