MAS PLIF Fixation System

Thoracolumbosacral Pedicle Screw System

NUVASIVE, INCORPORATED

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Mas Plif Fixation System.

Pre-market Notification Details

• Device ID: K142737
• 510k Number: K142737
• Device Name: MAS PLIF Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121
• Contact: Olga Lewis
• Correspondent: Olga Lewis; NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-23
• Decision Date: 2014-12-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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