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Sectra Orthopedic Package 18.2

by Sectra AB

Part of a family of 6 devices: see the family page

Ref 121

Sectra Orthopedic Package 18.2 is a device classified as Class IIa in the EU and Class II in the US made by Sectra AB, registered in EUDAMED on 4 Mar 2026 (Basic UDI-DI 735009281Orthopedic_App84), cleared under FDA 510(k) K031590 on 2 Oct 2003 and listed in FDA GUDID since 12 Jan 2025 (UDI-DI 07350092810562), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031590

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/MDR EUDAMED Number735009281Orthopedic_App84 Basic UDI-DI 07350092810562UDI-DIDate4 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350092810562 UDI-DI Date12 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031590 Date2 Oct 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 735009281Orthopedic_App84 registered 4 Mar 2026 Active
  • FDA 510(k) K031590 decided 2 Oct 2003 Active
  • FDA GUDID UDI-DI 07350092810562 listed 12 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031590
  2. Listed FDA GUDID 07350092810562
  3. Registered EUDAMED 735009281Orthopedic_App84

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  • Withdrawn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
Sectra Orthopaedic Package 18.2 EUDAMED
Sectra Orthopedic Package GUDID
Generic name
Radiology picture archiving and communication system workstation
Model / reference
121 EUDAMED
18.2 GUDID
Primary DI / UDI-DI
07350092810562
Basic UDI-DI
735009281Orthopedic_App84
Direct marketing DI
07350092810562
510(k) Number
FDA product code
LLZ
EMDN code
Z12139092 Various orthopaedic and traumatology instruments - medical device software
GMDN term
Radiology picture archiving and communication system workstation
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
121
GUDID
18.2
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: Radiology picture archiving and communication system workstation

Cleared under the same submission (K031590)

and 8 more cleared under K031590

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Sectra AB

See all devices from Sectra AB →

Properties

  • Measuring function
  • Prescription use
Other properties (23, all answered No)