NUVASIVE COROENT SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

NUVASIVE, INC.

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

Pre-market Notification Details

• Device ID: K071795
• 510k Number: K071795
• Device Name: NUVASIVE COROENT SYSTEM
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121
• Contact: Laetitia Cousin
• Correspondent: Laetitia Cousin; NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-02
• Decision Date: 2007-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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