FDA.report

510(k) K223765

Device
ATEC Lateral Navigation Instruments
Applicant
Alphatec Spine, Inc.
510(k) number
K223765
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-23
Date received
2022-12-15
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sandy Gill
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376541471ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541686ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541679ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541662ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541655ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541617ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541594ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541587ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541570ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541556ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541532ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541525ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541518ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376541501ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-12-18
00190376476131ATEC Lateral Navigation Disc Prep InstrumentsALPHATEC SPINE, INC.2024-03-28
00190376476186ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376476070ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376476155ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376476162ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376476179ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376476322ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376509792ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376509785ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376509778ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376509761ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376509754ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376494692ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376477107ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376476353ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26
00190376476339ATEC Lateral Navigation InstrumentsALPHATEC SPINE, INC.2023-08-26

Other 510(k) Records For Product Code OLO

510(k)DeviceApplicantDecision date
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
K260222Mako Total Knee ApplicationMako Surgical Corp.2026-02-25
K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.2026-02-20
K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc.2026-02-19
K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air MotorStryker Leibinger GmbH & Co KG2026-02-19
K254148VERTICALE GPS InstrumentsSilony Medical GmbH2026-02-19