FDA.reportPublic FDA data

Bolt Navigation

Primary DI
BN981BN002020
Brand
Bolt Navigation
Company
Circinus Medical Technology LLC
Model
BN002-02
Catalog number
BN002-02
Device description
Bolt Navigation Case
Published
2026-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
BN981BN002023PreviousHIBCC0
BN981BN002020PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
075673122
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
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
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
BN981BN002023Bolt Navigation BN002-02BN002-022024-11-15
B981BN00201101Bolt Navigation BN002-01-10BN002-01-102023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
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