Skip to content

Loqteq® Pr 3550-08-2

by aap Implantate AG

Ref PR 3550-08-2Model Bone plates (non-sterile)

Loqteq® Pr 3550-08-2 is a device classified as Class IIb in the EU and Class II in the US made by aap Implantate AG, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI B-04042409204296), cleared under FDA 510(k) K113652 on 30 Aug 2012 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 04042409204296), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113652

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042409204296 Basic UDI-DI 04042409204296UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042409204296 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113652 Date30 Aug 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042409204296 registered 28 Sep 2026 Active
  • FDA 510(k) K113652 decided 30 Aug 2012 Active
  • FDA GUDID UDI-DI 04042409204296 listed 18 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113652
  2. Listed FDA GUDID 04042409204296
  3. Registered EUDAMED B-04042409204296

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  • Withdrawn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
Loqteq®
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
PR 3550-08-2, Bone plates (non-sterile)
Primary DI / UDI-DI
04042409204296
Basic UDI-DI
B-04042409204296
510(k) Number
FDA product code
HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K113652)

and 8 more cleared under K113652

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from aap Implantate AG

See all devices from aap Implantate AG →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)