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510(k) K220648

OMF ASP System by Vha Dean — Product Code DZJ

K220648 is an FDA 510(k) premarket notification submitted by Vha Dean for the device "OMF ASP System". The FDA issued a decision of Substantially Equivalent on August 11, 2022. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. Vha Dean has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2022
Date Received
March 7, 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 Vha Dean

  • K222639 — VHA Radiotherapy Bolus (November 4, 2022)

Other clearances for product code DZJ

  • K261826 — VSP System (Titanium Palatal Splint) (June 3, 2026)
  • 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)
  • K220366 — EmbedMed (September 30, 2022)
  • K212570 — OsteoPlan System (February 11, 2022)
  • K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (June 28, 2021)
  • K193301 — coDiagnostiX (June 21, 2021)

FDA data resources