NuVasive® Lumbar Interbody Implants

Intervertebral Fusion Device With Bone Graft, Lumbar

NUVASIVE, INCORPORATED

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Lumbar Interbody Implants.

Pre-market Notification Details

• Device ID: K153782
• 510k Number: K153782
• Device Name: NuVasive® Lumbar Interbody Implants
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121
• Contact: Martin Yahiro
• Correspondent: Martin Yahiro; NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-31
• Decision Date: 2016-03-24
• Summary: summary