FDA.reportPublic FDA data

POINT ROBOTICS MEDTECH INC.

Primary DI
04719881650254
Brand
POINT ROBOTICS MEDTECH INC.
Company
POINT ROBOTICS MEDTECH INC.
Model
PSNF01-306
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
K230087000
K241130000
K252989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220241000“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.2022-08-09OLO
K230087000“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.2023-07-17OLO
K241130000“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.2024-07-24OLO
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
04719881650254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719881650254047198816502544719881650254

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
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
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05