FDA.reportPublic FDA data

PKS DRF 3 - ID 12.2

Primary DI
07290019120377
Brand
PKS DRF 3 - ID 12.2
Company
PATHKEEPER SURGICAL LTD
Model
MAS0007
Published
2024-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K222355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222355000PathKeeper SystemPathkeeper Surgical , Ltd.2023-03-08OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290019120374PackageGS11In Commercial Distribution
07290019120292PreviousGS10
07290019120377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001912037417290019120374
07290019120292072900191202927290019120292
07290019120377072900191203777290019120377

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)]; it may be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ENT, neurosurgery, CMF surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532374343
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019120018PKS Accessories Setup DRFMAS0001-012023-04-23
07290019120025PKS Patient Reference DRFMAS0002-012023-04-23
07290019120032PKS DRF 2-ID5.9MAS0003-012023-04-23
07290019120056PKS DRF 4-ID7.9MAS0005-012023-04-23
07290019120063PKS DRF 4-ID9.5x8MAS0006-012023-04-23
07290019120070PKS DRF 3-ID12.2MAS0007-012023-04-23
07290019120087PKS DRF 3-ID15MAS0008-012023-04-23
07290019120094PathKeeper SystemTPL0001-012023-04-23
07290019120179PKS Accessories Setup DRFMAS00012023-11-20
07290019120193PKS Patient Reference DRFMAS00022023-11-20
07290019120216PKS DRF 2-ID5.9MAS00032023-11-20
07290019120230PKS DRF 2-ID6.9MAS00042023-11-20
07290019120254PKS DRF 4-ID7.9MAS00052023-11-20
07290019120278PKS DRF 4-ID9.5x8MAS00062023-11-20
07290019120292PKS DRF 3-ID12.2MAS00072023-11-20
07290019120315PKS DRF 3-ID15MAS00082023-11-20
07290019120339PathKeeper Surgical Accessories KitKIT00022024-03-12
07290019120346PKS Patient Reference DRFMAS00022024-03-12
07290019120353PKS DRF 2 - ID 5.9MAS00032024-03-12
07290019120360PKS DRF 4 - ID 7.9MAS00052024-03-12

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