FOCUS Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Nvision Biomedical Technologies, LLC

The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Focus Pedicle Screw System.

Pre-market Notification Details

• Device ID: K180458
• 510k Number: K180458
• Device Name: FOCUS Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103 San Antonio, TX 78232
• Contact: Diana Langham
• Correspondent: Allison C. Komiyama; AcKnowledge Regulatory Strategies, LLC 2934 Hawthorn St. San Diego, CA 92104
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-20
• Decision Date: 2018-04-17
• Summary: summary

NIH GUDID Devices

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