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Ac Device Ldlg

by Lockdown Medical Ltd

Ref LDLG

Ac Device Ldlg 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 0506043360LENGTHGAUGNW), cleared under FDA 510(k) K091207 on 15 Feb 2011 and listed in FDA GUDID since 23 Feb 2017 (UDI-DI 05060433600333), 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 Number0506043360LENGTHGAUGNW Basic UDI-DI 05060433600333UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060433600333 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 0506043360LENGTHGAUGNW registered 4 Nov 2026 Active
  • FDA 510(k) K091207 decided 15 Feb 2011 Active
  • FDA GUDID UDI-DI 05060433600333 listed 23 Feb 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091207
  2. Listed FDA GUDID 05060433600333
  3. Registered EUDAMED 0506043360LENGTHGAUGNW

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  • Withdrawn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
Ligament graft, synthetic polymer
Model / Ref / Catalog
LDLG
Primary DI / UDI-DI
05060433600333
Basic UDI-DI
0506043360LENGTHGAUGNW
510(k) Number
FDA product code
FTY
EMDN code
V030204 Implant measurement devices not included in other classes
GMDN term
Ligament graft, synthetic polymer
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

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: Ligament graft, synthetic polymer

Cleared under the same submission (K091207)

and 8 more cleared under K091207

Similar devices

Also classified as Ligament graft, synthetic polymer.

Similar devices in this category

Other devices filed under IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES.

Other devices from Lockdown Medical Ltd

See all devices from Lockdown Medical Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)