COUGAR® LS Lateral Cage System And COUGAR® System

Intervertebral Fusion Device With Bone Graft, Lumbar

Medos International, Sarl

The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Cougar® Ls Lateral Cage System And Cougar® System.

Pre-market Notification Details

• Device ID: K162327
• 510k Number: K162327
• Device Name: COUGAR® LS Lateral Cage System And COUGAR® System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Medos International, Sarl Chemin-Blanc 38 Le Locle, CH 2400
• Contact: Eric Zhu
• Correspondent: Eric Zhu; DePuy Spine Inc. 325 Paramount Drive Raynham, MA 02767
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-19
• Decision Date: 2016-12-12
• Summary: summary