NUVASIVE BRIGADE ANTERIOR PLATE 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 Brigade Anterior Plate System.

Pre-market Notification Details

• Device ID: K121837
• 510k Number: K121837
• Device Name: NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121
• Contact: Cynthia Adams
• Correspondent: Cynthia Adams; 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: 2012-06-22
• Decision Date: 2012-07-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517140814	K121837	000
00887517132581	K121837	000
00887517133007	K121837	000
00887517148018	K121837	000
00887517148025	K121837	000
00887517148049	K121837	000
00887517148957	K121837	000
00887517148964	K121837	000
00887517140340	K121837	000
00887517140357	K121837	000
00887517140364	K121837	000
00887517121165	K121837	000
00887517121158	K121837	000
00887517140821	K121837	000
00887517141811	K121837	000
00887517141828	K121837	000
00887517073600	K121837	000
00887517120861	K121837	000
00887517120878	K121837	000
00887517120885	K121837	000
00887517121103	K121837	000
00887517121127	K121837	000
00887517121134	K121837	000
00887517140371	K121837	000
00887517140388	K121837	000
00887517162229	K121837	000
00887517162236	K121837	000
00887517162243	K121837	000
00887517162250	K121837	000
00887517162267	K121837	000
00887517163592	K121837	000
00887517163912	K121837	000
00887517163929	K121837	000
00887517163936	K121837	000
00887517163943	K121837	000
00887517162212	K121837	000
00887517162205	K121837	000
00887517140395	K121837	000
00887517140807	K121837	000
00887517141347	K121837	000
00887517141354	K121837	000
00887517141361	K121837	000
00887517141378	K121837	000
00887517141385	K121837	000
00887517141392	K121837	000
00887517141804	K121837	000
00887517148032	K121837	000
00887517163950	K121837	000