FDA.reportPublic FDA data

PKS DRF 4-ID7.9

Primary DI
17290019120053
Brand
PKS DRF 4-ID7.9
Company
PATHKEEPER SURGICAL LTD
Model
MAS0005-01
Published
2023-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
17290019120053PackageGS11In Commercial Distribution
07290019120056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001912005317290019120053
07290019120056072900191200567290019120056

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/localizers 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., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532374343
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOLO2026-07-23
00840466901035PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.OLO2026-07-21