CONFIDENCE™ High Viscosity Spinal Cement, VIPER® And EXPEDIUM® Fenestrated Screw Systems

Bone Cement, Posterior Screw Augmentation

Medos International Sàrl

The following data is part of a premarket notification filed by Medos International Sàrl with the FDA for Confidence™ High Viscosity Spinal Cement, Viper® And Expedium® Fenestrated Screw Systems.

Pre-market Notification Details

• Device ID: K160879
• 510k Number: K160879
• Device Name: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® And EXPEDIUM® Fenestrated Screw Systems
• Classification: Bone Cement, Posterior Screw Augmentation
• Applicant: Medos International Sàrl CHEMIN-BLANC 38 Le Locle, CH 2400
• Contact: Kirsten Lemuller
• Correspondent: Jeffrey Shiffman, J.d., M.s.; DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR Raynham, MA 02767
• Product Code: PML
• CFR Regulation Number: 888.3027 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-30
• Decision Date: 2016-12-20
• Summary: summary