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Drill Guide Array

by Brainlab SE

Ref 51839-03Model 51839

Drill Guide Array (51839-03) is a device classified as Class I in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K262257 on 30 Sep 2026 (2 earlier submissions), registered in EUDAMED on 19 May 2024 (Basic UDI-DI 4056481DrillGuideBody9G) and listed in FDA GUDID since 4 Jun 2024 (UDI-DI 04056481144753), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K262257

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK262257 Date30 Sep 2026DecidedStatusActive
United StatesGUDID listing GUDID Number04056481144753 UDI-DI Date4 Jun 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4056481DrillGuideBody9G Basic UDI-DI 04056481144753UDI-DIDate19 May 2024RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K262257 decided 30 Sep 2026 Active· +2 more in the status table
  • EUDAMED Basic UDI-DI 4056481DrillGuideBody9G registered 19 May 2024 Active
  • FDA GUDID UDI-DI 04056481144753 listed 4 Jun 2024 Listed

Timeline

5 dated events

  1. Registered EUDAMED 4056481DrillGuideBody9G
  2. Cleared FDA 510(k) K240701
  3. Listed FDA GUDID 04056481144753
  4. Cleared FDA 510(k) K252562
  5. Cleared FDA 510(k) K262257

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Surgical drill guide, reusable
Device name
Drill Guide Handle
Model / reference
51839, 51839-03
Primary DI / UDI-DI
04056481144753
Basic UDI-DI
4056481DrillGuideBody9G
Direct marketing DI
04056481144753
510(k) Number
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Surgical drill guide, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
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 I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Related devices

Category: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)