NUVASIVE HELIX REVOLUTION ACP SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

NUVASIVE, INC.

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

Pre-market Notification Details

• Device ID: K093804
• 510k Number: K093804
• Device Name: NUVASIVE HELIX REVOLUTION ACP SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• 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: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-11
• Decision Date: 2010-02-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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