NAJA™ Ligament Correction 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 Naja™ Ligament Correction System.

Pre-market Notification Details

• Device ID: K172206
• 510k Number: K172206
• Device Name: NAJA™ Ligament Correction 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: 2017-07-21
• Decision Date: 2018-04-10
• Summary: summary