FDA.reportPublic FDA data

Bolt Navigation

Primary DI
B981BN00201101
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8666823422info@boltnav.com

Regulatory Flags#

DUNS number
075673122
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
B981BN00201103Bolt Navigation BN002-01-10BN002-01-102023-03-15
B981BN0010101Bolt Navigation BN001-01-01BN001-01-012023-03-15

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