MODIFICATION TO: NUVASIVE SPHERX SYSTEM

Thoracolumbosacral Pedicle Screw System

NUVASIVE, INC.

The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Modification To: Nuvasive Spherx System.

Pre-market Notification Details

• Device ID: K090981
• 510k Number: K090981
• Device Name: MODIFICATION TO: NUVASIVE SPHERX SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121
• Contact: Han Fan
• Correspondent: Han Fan; NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• 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: 2009-04-07
• Decision Date: 2009-07-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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