NuVasive® VersaTie System

Bone Fixation Cerclage, Sublaminar

NUVASIVE, INCORPORATED

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

Pre-market Notification Details

• Device ID: K161265
• 510k Number: K161265
• Device Name: NuVasive® VersaTie System
• Classification: Bone Fixation Cerclage, Sublaminar
• Applicant: NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121
• Contact: Cynthia Adams
• Correspondent: Cynthia Adams; NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121
• Product Code: OWI
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-05
• Decision Date: 2016-07-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517948564	K161265	000
00887517984289	K161265	000
00887517984784	K161265	000
00887517984296	K161265	000
00887517794857	K161265	000
00887517721525	K161265	000
00887517709875	K161265	000
00887517721518	K161265	000