FDA.reportPublic FDA data

Bolt Navigation

Primary DI
B981BN00201103
Brand
Bolt Navigation
Company
Circinus Medical Technology LLC
Model
BN002-01-10
Catalog number
BN002-01-10
Device description
Bolt Navigation Sterile Case used with the Bolt Navigation System
Published
2023-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
B981BN00201103PrimaryHIBCC0
B981BN00201101Unit of UseHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
8666823422info@boltnav.com

Regulatory Flags#

DUNS number
075673122
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
BN981BN001021Bolt Navigation BN001-02BN001-022024-11-15
BN981BN002023Bolt Navigation BN002-02BN002-022024-11-15
B981BN0010101Bolt Navigation BN001-01-01BN001-01-012023-03-15
B981BN00201101Bolt Navigation BN002-01-10BN002-01-102023-03-15

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