Anteralign Spinal System With Titan NanoLOCK Surface Technology

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Anteralign Spinal System With Titan Nanolock Surface Technology.

Pre-market Notification Details

• Device ID: K212524
• 510k Number: K212524
• Device Name: Anteralign Spinal System With Titan NanoLOCK Surface Technology
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Contact: Elizabeth Hamilton
• Correspondent: Elizabeth Hamilton; Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Product Code: MAX
• Subsequent Product Code: OLO
• Subsequent Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-11
• Decision Date: 2021-12-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000128807	K212524	000
00763000128449	K212524	000
00763000128432	K212524	000
00763000128425	K212524	000
00763000128418	K212524	000
00763000128296	K212524	000
00763000128289	K212524	000
00763000128241	K212524	000
00763000128234	K212524	000
00763000128203	K212524	000
00763000128197	K212524	000
00763000128180	K212524	000
00763000128173	K212524	000
00763000127800	K212524	000
00763000128463	K212524	000
00763000128470	K212524	000
00763000128487	K212524	000
00763000128791	K212524	000
00763000128784	K212524	000
00763000128777	K212524	000
00763000128593	K212524	000
00763000128586	K212524	000
00763000128579	K212524	000
00763000128555	K212524	000
00763000128548	K212524	000
00763000128531	K212524	000
00763000128524	K212524	000
00763000128517	K212524	000
00763000128500	K212524	000
00763000128494	K212524	000
00763000127794	K212524	000
00763000127787	K212524	000
00763000127008	K212524	000
00763000126995	K212524	000
00763000126988	K212524	000
00763000126971	K212524	000
00763000126940	K212524	000
00763000126933	K212524	000
00763000126926	K212524	000
00763000126919	K212524	000
00763000126889	K212524	000
00763000126872	K212524	000
00763000127299	K212524	000
00763000128609	K212524	000
00763000127305	K212524	000
00763000127039	K212524	000
00763000127046	K212524	000
00763000127213	K212524	000
00763000127756	K212524	000
00763000127749	K212524	000
00763000127732	K212524	000
00763000127350	K212524	000
00763000127343	K212524	000
00763000127336	K212524	000
00763000127329	K212524	000
00763000127282	K212524	000
00763000127275	K212524	000
00763000127268	K212524	000
00763000127244	K212524	000
00763000127237	K212524	000
00763000127220	K212524	000
00763000516543	K212524	000
00763000198589	K212524	000
00763000193751	K212524	000
00763000193744	K212524	000
00763000193737	K212524	000
00763000193720	K212524	000
00763000193713	K212524	000
00763000198572	K212524	000
00763000198565	K212524	000
00763000198558	K212524	000
00763000198541	K212524	000
00763000198534	K212524	000
00763000198527	K212524	000
00763000198510	K212524	000
00763000198503	K212524	000
00763000193768	K212524	000
00763000193775	K212524	000
00763000193782	K212524	000
00763000198473	K212524	000
00763000193942	K212524	000
00763000193935	K212524	000
00763000193881	K212524	000
00763000193874	K212524	000
00763000193867	K212524	000
00763000193850	K212524	000
00763000193843	K212524	000
00763000193836	K212524	000
00763000193829	K212524	000
00763000193812	K212524	000
00763000193805	K212524	000
00763000193799	K212524	000
00763000198497	K212524	000
00763000198480	K212524	000
00763000508814	K212524	000
00763000508807	K212524	000
00763000508791	K212524	000
00763000226282	K212524	000
00763000226251	K212524	000
00763000226244	K212524	000
00763000226237	K212524	000
00763000204334	K212524	000
00763000128890	K212524	000
00763000128883	K212524	000
00763000128852	K212524	000
00763000128845	K212524	000
00763000128838	K212524	000
00763000508821	K212524	000
00763000509224	K212524	000
00763000510763	K212524	000
00763000198466	K212524	000
00763000198459	K212524	000
00763000198442	K212524	000
00763000198435	K212524	000
00763000198428	K212524	000
00763000198411	K212524	000
00763000198404	K212524	000
00763000198398	K212524	000
00763000128326	K212524	000
00763000128302	K212524	000
00763000510794	K212524	000
00763000510787	K212524	000
00763000510770	K212524	000
00763000128821	K212524	000