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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 the device name listed in this FDA 510(k) record. The listed applicant is Cousin Biotech Sas. It received FDA 510(k) clearance on 2018-08-29 under 510(k) 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. The listed applicant is Cousin Biotech Sas. The 510(k) number is K181799.

When did ResCUBE™ Ligament Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for ResCUBE™ Ligament Fixation System?

The FDA 510(k) record lists Cousin Biotech Sas as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cousin Biotech Sas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181086Cortical Fixation SystemsK172206NAJA™ Ligament Correction System

Related Devices (Code: OWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, 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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