FDA.reportPublic FDA data

POINT ROBOTICS MEDTECH INC.

Primary DI
04719881650117
Brand
POINT ROBOTICS MEDTECH INC.
Company
POINT ROBOTICS MEDTECH INC.
Model
PSNF01-000
Published
2026-04-09
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
K220241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220241000“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.2022-08-09OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719881650117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719881650117047198816501174719881650117

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.

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
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
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