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Bolt Navigation

FDA UDI

Class II (US FDA UDI)

by Circinus Medical Technology, Llc

Identity

Trade Name
Bolt Navigation FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
Bolt Navigation Unit, Gen 2.0 FDA UDI
Model / Reference
BN001-02 FDA UDI
Description
Bolt Navigation Unit, Gen 2.0 FDA UDI

Identifiers

Catalog Number
BN001-02 FDA UDI
Primary DI / UDI-DI
BN981BN001021 FDA UDI
510(k) Number
K213768 FDA UDI
FDA Product Code
OWB FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical planning/navigation-enhancement system

Bolt Navigation by Circinus Medical Technology, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical planning/navigation-enhancement system.

Cleared under the same submission

K213768 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Circinus Medical Technology, Llc

Sources (1)

  • FDA UDI f63b1587-1e2a-4246-9b7f-25b5e9c70b9f 36 fields · synced Jun 8, 2026