FDA.reportPublic FDA data

POINT ROBOTICS MEDTECH INC.

Primary DI
04719881650803
Brand
POINT ROBOTICS MEDTECH INC.
Company
POINT ROBOTICS MEDTECH INC.
Model
PSNI02-316
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K252989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252989000“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.2026-02-20OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719881650803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719881650803047198816508034719881650803

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
656383289
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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
04719881651299POINT ROBOTICS MEDTECH INC.PSNI03-3092026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647494CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647500CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647517CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647524CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647531CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647548CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647555CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647562CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647579CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647586CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647593CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647609CROSSNAV CONDUITMedos International SàrlOLO2026-07-09