STRUXXURE®-L And STRUXXURE®-A Plate System

Appliance, Fixation, Spinal Intervertebral Body

Nexxt Spine LLC

The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Struxxure®-l And Struxxure®-a Plate System.

Pre-market Notification Details

• Device ID: K202192
• 510k Number: K202192
• Device Name: STRUXXURE®-L And STRUXXURE®-A Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Nexxt Spine LLC 14425 Bergen Blvd, Suite B Noblesville, IN 46060
• Contact: Andy Elsbury
• Correspondent: Karen E. Warden; BackRoads Consulting PO Box 566 Chesterland, OH 44026
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-05
• Decision Date: 2020-09-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889929058244	K202192	000
00889929040874	K202192	000
00889929040881	K202192	000
00889929040898	K202192	000
00889929040904	K202192	000
00889929040911	K202192	000
00889929040928	K202192	000
00889929040935	K202192	000
00889929040942	K202192	000
00889929040959	K202192	000
00889929040966	K202192	000
00889929040867	K202192	000
00889929040850	K202192	000
00889929058251	K202192	000
00889929055946	K202192	000
00889929055953	K202192	000
00889929043059	K202192	000
00889929040607	K202192	000
00889929040614	K202192	000
00889929040638	K202192	000
00889929040645	K202192	000
00889929040836	K202192	000
00889929040843	K202192	000
00889929040973	K202192	000
00889929040980	K202192	000
00889929041239	K202192	000
00889929041246	K202192	000
00889929041253	K202192	000
00889929041260	K202192	000
00889929041277	K202192	000
00889929041284	K202192	000
00889929042854	K202192	000
00889929042960	K202192	000
00889929042977	K202192	000
00889929042984	K202192	000
00889929041222	K202192	000
00889929041215	K202192	000
00889929040997	K202192	000
00889929041000	K202192	000
00889929041017	K202192	000
00889929041024	K202192	000
00889929041154	K202192	000
00889929041161	K202192	000
00889929041178	K202192	000
00889929041185	K202192	000
00889929041192	K202192	000
00889929041208	K202192	000
00889929042991	K202192	000