FDA.reportPublic FDA data

POINT ROBOTICS MEDTECH INC.

Primary DI
04719881650995
Brand
POINT ROBOTICS MEDTECH INC.
Company
POINT ROBOTICS MEDTECH INC.
Model
PSSS01-409
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
04719881650995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719881650995047198816509954719881650995

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
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07