FDA.report

Geniant Cranial

Primary DI
08800050901782
Brand
Geniant Cranial
Company
KOH YOUNG TECHNOLOGY INC.
Model
MN30-KH00001
Device description
O-Frame
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K241333000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241333000Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.2025-01-17HAW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800050901782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800050901782088000509017828800050901782

GMDN Terms

TermDefinition
Neurological 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 neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods

Method

Regulatory Flags

DUNS number
695406977
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800050904769Geniant CranialKY-PPR-0030-A2026-03-09
08800050904776Geniant CranialM_MN30-QC000002026-03-09
08800050901287Geniant CranialM_MN30-CMF00002025-02-20
08800050901294Geniant CranialM_MN30-CMM00002025-02-20
08800050901300Geniant CranialM_MN30-CMR00002025-02-20
08800050901317Geniant CranialM_MN30-CMRN0002025-02-20
08800050901324Geniant CranialM_MN30-CMP00002025-02-20
08800050901331Geniant CranialM_MN30-CMS00002025-02-20
08800050901348Geniant CranialM_MN30-CML00002025-02-20
08800050901355Geniant CranialM_MN30-CMU00002025-02-20
08800050901362Geniant CranialM_MN30-CME00002025-02-20
08800050901379Geniant CranialM_MN30-CMG00002025-02-20
08800050901386Geniant CranialM_MN30-CMH00002025-02-20
08800050901393Geniant CranialM_MN30-CLL00002025-02-20
08800050901409Geniant CranialM_MN30-CMB00002025-02-20
08800050901416Geniant CranialM_MN30-CMC00002025-02-20
08800050901423Geniant CranialM_MN30-CMD00002025-02-20
08800050901430Geniant CranialM_MN30-CMA00002025-02-20
08800050901447Geniant CranialM_MN30-CMAN0002025-02-20
08800050901454Geniant CranialM_MN30-CMQ00002025-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00873263009468microTargeting™ PlatformFHC, INC.HAW2026-03-16
00873263009475microTargeting™ Measurement ProbeFHC, INC.HAW2026-03-16
08800050904769Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
08800050904776Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
00763000738334AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738341AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738402AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738433AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
04056481147808Drill Depth Stop Cranial 4.9 mmBrainlab SEHAW2026-02-11
00873263009451microTargeting™ Drill GuideFHC, INC.HAW2026-02-10
00860009258105COMPASS CYGNUS-PFS IGS SystemCompass InternationalHAW2026-01-29
00860009258112COMPASS Stereotactic SystemCompass InternationalHAW2026-01-29
07630345728975Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
07630699701792Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
00873263009574STar™ Drive Frame AdapterFHC, INC.HAW2026-01-25
07630030846656Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
07630030846663Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
00763000738488AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-01-01
00860012211906SOLOPASS 2.0 Patient Interface DeviceinTRAvent Medical Partners, L.P.HAW2025-12-11
00763000337292N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337308N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337315N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337322N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000340261N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405144N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405151N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000927264MedtronicMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000943219N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
07340201502273Leksell Stereotactic SystemElekta Solutions ABHAW2025-09-17