FDA 510(k)

Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition

K-Number: K222383 · 2022-09-29

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2022-09-29

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2022-09-29 under approval number K222383. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition?

Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition is a medical device that received FDA 510(k) clearance on 2022-09-29. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K222383.

When was Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition approved by the FDA?

Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition received FDA 510(k) clearance on 2022-09-29, under approval number K222383.

What company makes Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition?

Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition?

The FDA product code for Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition is OLO.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025)

Other Devices by Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device

View all 76 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.