COROENT INTERLOCK SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Cervical

NUVASIVE, INC.

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

Pre-market Notification Details

• Device ID: K102547
• 510k Number: K102547
• Device Name: COROENT INTERLOCK SYSTEM
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121
• Contact: Sheila Bruschi
• Correspondent: Sheila Bruschi; NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-03
• Decision Date: 2011-02-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517341518	K102547	000
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