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Bolt Navigation BN002-02

by Circinus Medical Technology, LLC 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberBN981BN002020 UDI-DI Date25 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bolt Navigation
Generic Name
Surgical planning/navigation-enhancement system
Model / Ref / Catalog
BN002-02
Primary DI / UDI-DI
BN981BN002020
510(k) Number
FDA Product Code
OWB
GMDN Term
Surgical planning/navigation-enhancement system
Device Class
Class II
Regulation Number
892.1650
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K213768)

Other devices from Circinus Medical Technology, LLC

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No