FDA.reportPublic FDA data

Bolt Navigation

Primary DI
BN981BN002023
Brand
Bolt Navigation
Company
Circinus Medical Technology LLC
Model
BN002-02
Catalog number
BN002-02
Device description
Bolt Navigation Case
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213768000Bolt Navigation SystemCircinus Medical Technology, LLC2022-12-01OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
BN981BN002023PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
075673122
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
BN981BN002020Bolt NavigationBN002-02BN002-022026-09-25
BN981BN00202BX101Bolt NavigationBN002-02BX10BN002-02BX102026-09-25
B981BN00201103Bolt NavigationBN002-01-10BN002-01-102023-03-15
B981BN0010101Bolt NavigationBN001-01-01BN001-01-012023-03-15
BN981BN001021Bolt Navigation BN001-02BN001-022024-11-15
B981BN00201101Bolt Navigation BN002-01-10BN002-01-102023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376649474CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONOWB2026-08-14
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.OWB2026-07-08
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00198715128956AngiowaveAngioWave Imaging, LLCOWB2026-05-09
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
04056481145613Vascular Navigation PADBrainlab SEOWB2025-09-11
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHOWB2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHOWB2025-07-30
00850073646007TrackXTrackX Technology, LLCOWB2025-07-24
00850073646014TrackXTrackX Technology, LLCOWB2025-07-24
00841962119467Alpine StirrupsQfixOWB2025-07-09