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Navigated Infinity ™ Instruments NAVNS3606010

by Medtronic Sofamor Danek, Inc.

Ref NAVNS3606010

Navigated Infinity ™ Instruments NAVNS3606010 is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Sofamor Danek, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-00643169862494), cleared under FDA 510(k) K173338 on 18 Jan 2018 and listed in FDA GUDID since 2 Aug 2018 (UDI-DI 00643169862494), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173338

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00643169862494 Basic UDI-DI 00643169862494UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00643169862494 UDI-DI Date2 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173338 Date18 Jan 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00643169862494 registered 22 Oct 2026 Active
  • FDA 510(k) K173338 decided 18 Jan 2018 Active
  • FDA GUDID UDI-DI 00643169862494 listed 2 Aug 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173338
  2. Listed FDA GUDID 00643169862494
  3. Registered EUDAMED B-00643169862494

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Navigated Infinity ™ Instruments
Generic name
Fluted surgical drill bit, reusable
Device name
Nav Drill Bit
Model / reference
NAVNS3606010
Primary DI / UDI-DI
00643169862494
Basic UDI-DI
B-00643169862494
510(k) Number
FDA product code
OLO
EMDN code
P091303 Orthopaedic implant drill bits, single-use
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fluted surgical drill bit, reusable

Cleared under the same submission (K173338)

and 5 more cleared under K173338

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)