Home / 510(k) Clearances / K220366

510(k) K220366

EmbedMed by 3D Lifeprints UK , Ltd. — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2022
Date Received
February 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Wire, And Bone Drill, Manual
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by 3D Lifeprints UK , Ltd.

  • K221943 — EmbedMed (February 1, 2023)

Other clearances for product code DZJ

  • K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (February 21, 2025)
  • K242263 — TECHFIT DISRP® System (December 11, 2024)
  • K231520 — tmCMF Solution (October 2, 2023)
  • K230276 — TECHFIT DISRP® System (June 23, 2023)
  • K223024 — MedCAD AccuPlan System (March 7, 2023)
  • K220648 — OMF ASP System (August 11, 2022)
  • K212570 — OsteoPlan System (February 11, 2022)
  • K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (June 28, 2021)
  • K193301 — coDiagnostiX (June 21, 2021)
  • K210347 — VSP System (April 26, 2021)