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3D-Shaper 2.11

by 3D-Shaper Medical S.L.

3D-Shaper 2.11 is a surgical simulation system (FDA Class II; FDA product code KGI, Densitometer, Bone) made by 3D-Shaper Medical S.L., cleared under FDA 510(k) K220822 on 9 Dec 2022, registered in EUDAMED and listed in FDA GUDID since 4 Oct 2023 (UDI-DI 08437021740028), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220822

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08437021740028 UDI-DI Date4 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK220822 Date9 Dec 2022IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K220822 decided 9 Dec 2022 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08437021740028 listed 4 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220822
  2. Listed FDA GUDID 08437021740028

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  • Withdrawn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
3D-Shaper
Generic name
Surgical simulation system
Model / reference
2.11
Primary DI / UDI-DI
08437021740028
510(k) Number
FDA product code
KGI
GMDN term
Surgical simulation system
Device class
Class II
Regulation number
892.1170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical simulation system

Similar devices

Other devices filed under FDA product code KGI (Densitometer, Bone).

Other devices from 3D-Shaper Medical S.L.

  • 3D-Shaper 2.14

    Class II

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)