COROENT SMALL INTERBODY SYSTEM

Intervertebral Fusion Device With Bone Graft, Cervical

NUVASIVE, INC.

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

Pre-market Notification Details

• Device ID: K140003
• 510k Number: K140003
• Device Name: COROENT SMALL INTERBODY SYSTEM
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121
• Contact: Cynthia Adams
• Correspondent: Cynthia Adams; NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-02
• Decision Date: 2014-04-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00887517353054	K140003	000
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00887517350046	K140003	000
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00887517350022	K140003	000
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00887517349286	K140003	000
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