VIPER SYSTEMS

Thoracolumbosacral Pedicle Screw System

JOHNSON & JOHNSON

The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Viper Systems.

Pre-market Notification Details

• Device ID: K111571
• 510k Number: K111571
• Device Name: VIPER SYSTEMS
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 -0151
• Contact: Daphney Germain-kolawole
• Correspondent: Daphney Germain-kolawole; JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 -0151
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-06
• Decision Date: 2011-07-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034266602	K111571	000
10705034265728	K111571	000
10705034265704	K111571	000
10705034265698	K111571	000
10705034265650	K111571	000
10705034265643	K111571	000
10705034265629	K111571	000
10705034265605	K111571	000
10705034265582	K111571	000
10705034265537	K111571	000
10705034266367	K111571	000
10705034266343	K111571	000
10705034266329	K111571	000
10705034266305	K111571	000
10705034266299	K111571	000
10705034266251	K111571	000
10705034265742	K111571	000
10705034265766	K111571	000
10705034265773	K111571	000
10705034266589	K111571	000
10705034266565	K111571	000
10705034266541	K111571	000
10705034266534	K111571	000
10705034266497	K111571	000
10705034266480	K111571	000
10705034266466	K111571	000
10705034266442	K111571	000
10705034266428	K111571	000
10705034266411	K111571	000
10705034266374	K111571	000
10705034265865	K111571	000
10705034265841	K111571	000
10705034265827	K111571	000
10705034265810	K111571	000
10705034265889	K111571	000