ResCUBE™ Ligament Fixation System

Bone Fixation Cerclage, Sublaminar

Cousin Biotech S.A.S.

The following data is part of a premarket notification filed by Cousin Biotech S.a.s. with the FDA for Rescube™ Ligament Fixation System.

Pre-market Notification Details

• Device ID: K181799
• 510k Number: K181799
• Device Name: ResCUBE™ Ligament Fixation System
• Classification: Bone Fixation Cerclage, Sublaminar
• Applicant: Cousin Biotech S.A.S. 8 Rue De L'abbe Bonpain Wervicq-sud, FR 59117
• Contact: Mathilde Collet
• Correspondent: Franck Pelletier; Cousin Biotech S.A.S. 8 Rue De L'abbe Bonpain Wervicq-sud, FR 59117
• Product Code: OWI
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-05
• Decision Date: 2018-08-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760185576109	K181799	000