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