FDA.reportPublic FDA data

PKS DRF 3-ID12.2

Primary DI
07290019120292
Brand
PKS DRF 3-ID12.2
Company
PATHKEEPER SURGICAL LTD
Model
MAS0007
Published
2023-11-20
Public version status
Update
Distribution status
Not 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
17290019120305PackageGS11Not in Commercial Distribution
07290019120292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001912030517290019120305
07290019120292072900191202927290019120292

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation/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; it may be intended to overlay pre-acquired radiological images or real-time data [e.g., ultrasound (US)] for surgical navigation, and 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
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
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
07290019120377PKS DRF 3 - ID 12.2MAS00072024-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150067633Stealth AXiS Advanced Spine Referencing KitMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
04056481146429Automatic RegsitrationBrainlab SEOLO2026-02-20
00810180350051ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350099ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350112ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
006283415213837D Surgical Universal Array (5)7D Surgical ULCOLO2025-07-28
006283415213907D Surgical Universal Array (6)7D Surgical ULCOLO2025-07-28
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
04056481146320Alignment Software SpineBrainlab SEOLO2025-06-16
00850042604311Paradigm Drill Guide TrocarProprio, Inc.OLO2025-06-09
00810180350266ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350433ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350525ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350556ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350563ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350693ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00850030914347SkyWalkerMicroport Navibot International LLCOLO2025-04-24
00850030914354SkyWalkerMicroport Navibot International LLCOLO2025-04-24