Aspida® Anterior Lumbar Plating System

Appliance, Fixation, Spinal Intervertebral Body

Alphatec Spine, Inc.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Aspida® Anterior Lumbar Plating System.

Pre-market Notification Details

• Device ID: K182808
• 510k Number: K182808
• Device Name: Aspida® Anterior Lumbar Plating System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008
• Contact: Ruby Zheng
• Correspondent: Ruby Zheng; Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-03
• Decision Date: 2018-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190376159638	K182808	000
00190376115979	K182808	000
00190376115955	K182808	000
00190376115948	K182808	000
00190376115931	K182808	000
00190376115924	K182808	000
00190376115917	K182808	000
00190376115900	K182808	000
00190376115894	K182808	000
00190376115887	K182808	000
00190376115962	K182808	000
00190376115986	K182808	000
00190376115993	K182808	000
00190376159621	K182808	000
00190376159614	K182808	000
00190376159607	K182808	000
00190376159591	K182808	000
00190376159584	K182808	000
00190376116044	K182808	000
00190376116037	K182808	000
00190376116020	K182808	000
00190376116013	K182808	000
00190376116006	K182808	000
00190376115870	K182808	000