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Ac Device LDI627/S

by Lockdown Medical Ltd

Ref LDIN627/S

Ac Device LDI627/S (LDIN627/S) is a device classified as Class IIa in the EU and Class I in the US made by Lockdown Medical Ltd, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 0506043360AODRILLWR), cleared under FDA 510(k) K091207 on 15 Feb 2011 and listed in FDA GUDID since 23 Feb 2017 (UDI-DI 05060433600319), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091207

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/MDR EUDAMED Number0506043360AODRILLWR Basic UDI-DI 05060433600319UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060433600319 UDI-DI Date23 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK091207 Date15 Feb 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0506043360AODRILLWR registered 4 Nov 2026 Active
  • FDA 510(k) K091207 decided 15 Feb 2011 Active
  • FDA GUDID UDI-DI 05060433600319 listed 23 Feb 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091207
  2. Listed FDA GUDID 05060433600319
  3. Registered EUDAMED 0506043360AODRILLWR

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  • Withdrawn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

Trade name
Ac Device
Generic name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
LDIN627/S, LDI627/S
Primary DI / UDI-DI
05060433600319
Basic UDI-DI
0506043360AODRILLWR
510(k) Number
FDA product code
HTW
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 2.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
LDIN627/S
GUDID
LDI627/S
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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, single-use

Cleared under the same submission (K091207)

and 8 more cleared under K091207

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Lockdown Medical Ltd

See all devices from Lockdown Medical Ltd →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)