NuVasive® Camber Laminoplasty System

Orthosis, Spine, Plate, Laminoplasty, Metal

NuVasive, Incorporated

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

Pre-market Notification Details

• Device ID: K191169
• 510k Number: K191169
• Device Name: NuVasive® Camber Laminoplasty System
• Classification: Orthosis, Spine, Plate, Laminoplasty, Metal
• Applicant: NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Contact: Thao Huynh
• Correspondent: Thao Huynh; NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Product Code: NQW
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-01
• Decision Date: 2019-07-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517995940	K191169	000
00887517995759	K191169	000
00887517995742	K191169	000
00887517995735	K191169	000
00887517995728	K191169	000
00887517995711	K191169	000
00887517995704	K191169	000
00887517995698	K191169	000
00887517995681	K191169	000
00887517995674	K191169	000
00887517995667	K191169	000
00887517995650	K191169	000
00887517995643	K191169	000
00887517995636	K191169	000
00887517995629	K191169	000
00887517995612	K191169	000
00887517995766	K191169	000
00887517995773	K191169	000
00887517995780	K191169	000
00887517995933	K191169	000
00887517995926	K191169	000
00887517995919	K191169	000
00887517995902	K191169	000
00887517995896	K191169	000
00887517995889	K191169	000
00887517995872	K191169	000
00887517995865	K191169	000
00887517995858	K191169	000
00887517995841	K191169	000
00887517995834	K191169	000
00887517995827	K191169	000
00887517995810	K191169	000
00887517995803	K191169	000
00887517995797	K191169	000
00887517995605	K191169	000