FDA.reportPublic FDA data

Compass International

Primary DI
B169CYGSAP102A0
Brand
Compass International
Company
Compass International
Model
CYG-SAP-10-2A
Catalog number
CYG-SAP-10-2A
Device description
Cygnus-PFS Surgical Arm w/Detachable End
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B169CYGSAP102A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic neuronavigation/planning systemA mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809466410
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009258129COMPASS CT Adaptation Stereotactic SystemPION-20CT-NBAR-102026-03-18
00860009258136COMPASS Stereotactic Retractor SystemPION-20RE-202026-03-18
00860009258105COMPASS CYGNUS-PFS IGS SystemCYG-PFSN-10TPCYG-PFSN-10TP2026-01-29
00860009258112COMPASS Stereotactic SystemPION-20PION-202026-01-29
B169RU1500Compass InternationalRU-150RU-1502016-08-26
B169RU3000Compass InternationalRU-300RU-3002016-08-26
B169CYGERG10D0Compass InternationalCYG-ERG-10DCYG-ERG-10D2016-08-12
B169CYG10B2TP0Compass InternationalCYG-10-B2TPCYG-10-B2TP2016-09-13
B169CYG10BTP0Compass InternationalCYG-10-BTPCYG-10-BTP2016-09-13
B169CYG10LPTP0Compass InternationalCYG-10-LPTPCYG-10-LPTP2016-09-13
B169CYG10LSTP0Compass InternationalCYG-10-LSTPCYG-10-LSTP2016-09-13
B169CYG10PTP0Compass InternationalCYG-10-PTPCYG-10-PTP2016-09-13
B169CYG10STP0Compass InternationalCYG-10-STPCYG-10-STP2016-09-13
B169CYG14FSCT100Compass InternationalCYG-14F-SCT10CYG-14F-SCT102016-09-13
B169CYG4FCT100Compass InternationalCYG-4F-CT10CYG-4F-CT102016-08-12
B169CYG4FCT10TP0Compass InternationalCYG-4F-CT10TPCYG-4F-CT10TP2016-09-13
B169CYG5FNPT100Compass InternationalCYG-5F-NPT10CYG-5F-NPT102016-09-13
B169CYG5FNPT10TP0Compass InternationalCYG-5F-NPT10TPCYG-5F-NPT10TP2016-09-13
B169CYG9FSCT100Compass InternationalCYG-9F-SCT10CYG-9F-SCT102016-09-13
B169CYG9FSCT10TP0Compass InternationalCYG-9F-SCT10TPCYG-9F-SCT10TP2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006701PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00650551006718PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00650551006725PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00650551006732PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00763000811129MedtronicMEDTRONIC NAVIGATION, INC.HAW2026-06-07
00860012056828Zeta Navigation SystemZeta Surgical Inc.HAW2026-06-02
08720892330826Ball Joint Guide Array (BJGA)-Navigation SetBayer Medical Care B.V.HAW2026-04-24
08720892330833Ball Joint Guide Array (BJGA)-Guide SetBayer Medical Care B.V.HAW2026-04-24
07340201501887Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2025-03-31
10381780542278CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542285CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542292Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-03
G076A012354A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500578N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327503265N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
10603295522850VELYSDEPUY (IRELAND)HAW2021-07-30
07613327413076n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413090n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413205n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
10603295493624SIGMADEPUY ORTHOPAEDICS, INC.HAW2018-04-19
10650551098277PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2018-01-28
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252252CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252351Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252368Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252375CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14