FDA.report

510(k) K232140

Device
OTS Hip
Applicant
Ortoma AB
510(k) number
K232140
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-11
Date received
2023-07-18
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
No

Related Records

Applicant Contact

Contact
Linus Byström
Address
Falkenbergsgatan 3 Gothenburg SE 41285 41285

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07350137520593Inserter Adapter OTD Pinnacle StraightOrtoma AB (Publ)2024-10-03
07350137520647Measurement Screw 15 mmOrtoma AB (Publ)2024-10-03
07350137520654Measurement Screw 8 mmOrtoma AB (Publ)2024-10-03
07350137520661Threaded Pin 4x150 mmOrtoma AB (Publ)2024-10-03
07350137521019Inserter Adapter OTD StraightOrtoma AB (Publ)2024-10-03
07350137520081Reamer Adapter OTDOrtoma AB (Publ)2024-10-01
07350137520005OTS Hip PlanOrtoma AB (Publ)2024-10-01
07350137520029OTS Hip Guide SWOrtoma AB (Publ)2024-10-01
07350137520036Stylet and PinOrtoma AB (Publ)2024-10-01
07350137520043Pointer HolderOrtoma AB (Publ)2024-10-01
07350137520067Pointer OTOrtoma AB (Publ)2024-10-01
07350137520074Attachment Adapter Fix OTOrtoma AB (Publ)2024-10-01
17350137520521Tracer SetOrtoma AB (Publ)2024-10-01
07350137520098Inserter Adapter OTDOrtoma AB (Publ)2024-10-01
07350137520678Measurement Screw DriverOrtoma AB (Publ)2024-10-01
07350137520692OTS Hip Solution PinnacleOrtoma AB (Publ)2024-10-01
07350137520708OTS Hip Solution EmphasysOrtoma AB (Publ)2024-10-01
07350137520906OTS Hip Guide Reusable Set Pinnacle Ortoma AB (Publ)2024-10-01
07350137520913OTS Hip Guide Reusable Set EmphasysOrtoma AB (Publ)2024-10-01
07350137520968Attachment Adapter Twin OTOrtoma AB (Publ)2024-10-01
07350137521002Threaded Pin DriverOrtoma AB (Publ)2024-10-01
07350137521026Calibration Adapter Unit OTDOrtoma AB (Publ)2024-10-01
07350137521033Calibration Adapter Unit OTD EmphasysOrtoma AB (Publ)2024-10-01
07350137521101OTS HipOrtoma AB (Publ)2024-10-01

Other 510(k) Records For Product Code OLO

510(k)DeviceApplicantDecision date
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
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
K254148VERTICALE GPS InstrumentsSilony Medical GmbH2026-02-19