VIPER PRIME™ Screws With Fenestrations

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™ Screws With Fenestrations.

Pre-market Notification Details

• Device ID: K170543
• 510k Number: K170543
• Device Name: VIPER PRIME™ Screws With Fenestrations
• 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
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-24
• Decision Date: 2017-05-04
• Summary: summary