VIPER PRIME™ Additions To The VIPER® System

Thoracolumbosacral Pedicle Screw System

MEDOS INTERNATIONAL, SARL

The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Viper Prime™ Additions To The Viper® System.

Pre-market Notification Details

• Device ID: K162912
• 510k Number: K162912
• Device Name: VIPER PRIME™ Additions To The VIPER® System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDOS INTERNATIONAL, SARL CHEMIN-BLANC 38 Le Locle, CH 2400
• Contact: Karen Sylvia
• Correspondent: Laura Bleyendaal; DEPUY SYNTHES 325 Paramount Drive Raynham, MA 02767
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-17
• Decision Date: 2016-12-08
• Summary: summary