FDA.reportPublic FDA data

510(k) K221180

Device
Anteralign(TM) Spinal System With Titan NanoLOCK Surface Technology Navigated Instruments
Applicant
Medtronic Sofamor Danek USA, INC
510(k) number
K221180
Product code
OLO  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-25
Date received
2022-04-25
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Elizabeth Hamilton
Address
1800 Pyramid Pl. Memphis TN US 38132 38132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.2026-06-02
K261060Navigated LLIF Impactable TrackerTyber Medical, LLC2026-05-29
K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL2026-05-26
K260329Ion-C Navigation InstrumentsSurGenTec, LLC2026-05-22
K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-05-21
K252880Pytheas Your Guided TrajectoryPytheas Navigation Sas2026-05-11
K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.2026-04-16
K254158SPINEART Navigation Instrument SystemSpineart SA2026-04-09
K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL2026-03-27
K260601REAL INTELLIGENCE™ CORI™Blue Belt Technologies, Inc.2026-03-26
K252037CUVIS-joint (CJ150)Curexo, Inc.2026-03-25
K253604TiLink-L Navigation InstrumentsSurGenTec, LLC2026-03-20
K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC2026-03-18
K260546Q Pedicle InstrumentsK2m, Inc.2026-03-17
K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.2026-03-03

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases