VIPER PRIME™ Screws, VIPER PRIME™ Screws With Fenestrations, EXPEDIUM® Verse 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, Viper Prime™ Screws With Fenestrations, Expedium® Verse Screws With Fenestrations.

Pre-market Notification Details

• Device ID: K173095
• 510k Number: K173095
• Device Name: VIPER PRIME™ Screws, VIPER PRIME™ Screws With Fenestrations, EXPEDIUM® Verse Screws With Fenestrations
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400
• Contact: Thao Le
• Correspondent: Thao Le; DePuy Synthes 325 Paramount Dr. Raynham, MA 02767
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-29
• Decision Date: 2017-10-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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