FDA.reportPublic FDA data

POINT ROBOTICS MEDTECH INC.

Primary DI
04719881650926
Brand
POINT ROBOTICS MEDTECH INC.
Company
POINT ROBOTICS MEDTECH INC.
Model
PSSS01-402
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252755000POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.2026-01-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719881650926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719881650926047198816509264719881650926

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It typically consists of an operator's console featuring a robotic surgical arm(s) and a video camera used to track the robotic instrumentation. The input to the computer is usually by means of an existing CT or MRI scan. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Regulatory Flags#

DUNS number
656383289
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719881650414POINT ROBOTICS MEDTECH INC.PSHF01-4012026-04-13
04719881650421POINT ROBOTICS MEDTECH INC.PSHF01-4022026-04-13
04719881650438POINT ROBOTICS MEDTECH INC.PSNI01-4092026-04-13
04719881650452POINT ROBOTICS MEDTECH INC.PSNI01-4012026-04-13
04719881650469POINT ROBOTICS MEDTECH INC.PSNI01-4022026-04-13
04719881650476POINT ROBOTICS MEDTECH INC.PSNI01-4032026-04-13
04719881650483POINT ROBOTICS MEDTECH INC.PSNI01-4042026-04-13
04719881650698POINT ROBOTICS MEDTECH INC.PSNI02-3052026-04-13
04719881650742POINT ROBOTICS MEDTECH INC.PSNI02-3102026-04-13
04719881650773POINT ROBOTICS MEDTECH INC.PSNI02-3132026-04-13
04719881650780POINT ROBOTICS MEDTECH INC.PSNI02-3142026-04-13
04719881650797POINT ROBOTICS MEDTECH INC.PSNI02-3152026-04-13
04719881650803POINT ROBOTICS MEDTECH INC.PSNI02-3162026-04-13
04719881651220POINT ROBOTICS MEDTECH INC.PSNI03-3022026-04-13
04719881651237POINT ROBOTICS MEDTECH INC.PSNI03-3032026-04-13
04719881651244POINT ROBOTICS MEDTECH INC.PSNI03-3042026-04-13
04719881651251POINT ROBOTICS MEDTECH INC.PSNI03-3052026-04-13
04719881651268POINT ROBOTICS MEDTECH INC.PSNI03-3062026-04-13
04719881651275POINT ROBOTICS MEDTECH INC.PSNI03-3072026-04-13
04719881651282POINT ROBOTICS MEDTECH INC.PSNI03-3082026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376658933Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376658940Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376659053Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729435Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres MBrainlab SEOLO2026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres MLBrainlab SEOLO2026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres LBrainlab SEOLO2026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1Brainlab SEOLO2026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2Brainlab SEOLO2026-10-29
04056481147693Quip Instrument Adapter Clamp Size SBrainlab SEOLO2026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size MBrainlab SEOLO2026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size LBrainlab SEOLO2026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XLBrainlab SEOLO2026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular InstrumentsBrainlab SEOLO2026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical InstrumentsBrainlab SEOLO2026-10-29
04056481147754Quip Instrument Adapter Extension 50 mmBrainlab SEOLO2026-10-29
04056481147761Quip Instrument Adapter 45° AngledBrainlab SEOLO2026-10-29
04250337121626joimax® Intracs® EM Patient Tracker 3DJoimax GmbHOLO2026-10-29
04250337118985J-Needle Navi WL 120, trocar, 11 GJoimax GmbHOLO2026-10-28
00887868578922ROSA® KneeOrthosoft IncOLO2026-10-27
00887868578939ROSA Partial Knee SoftwareOrthosoft IncOLO2026-10-27
00887868581090ROSA® RoboticsOrthosoft IncOLO2026-10-27
00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
00889024671270ROSA® HipOrthosoft IncOLO2026-10-27
04056481145323Patient Reference Carbon-Clamp Spine & TraumaBrainlab SEOLO2026-10-27
04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
04056481148225Sterilization Tray Accessories Spine MISBrainlab SEOLO2026-10-27
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26