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3D-Shaper 2.14

by 3D-Shaper Medical S.L.

3D-Shaper 2.14 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) K251022 on 5 Sep 2025 and listed in FDA GUDID since 12 May 2026 (UDI-DI 08437021740066), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K251022

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08437021740066 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK251022 Date5 Sep 2025IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251022 decided 5 Sep 2025 Active
  • FDA GUDID UDI-DI 08437021740066 listed 12 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251022
  2. Listed FDA GUDID 08437021740066

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
3D-Shaper
Generic name
Surgical simulation system
Model / reference
2.14
Primary DI / UDI-DI
08437021740066
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

Similar devices

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

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

  • 3D-Shaper 2.11

    Class II

Properties

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