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510(k) K201353

CenterMed Patient Matched Assisted Surgical Planning (ASP) System by Centermed, Inc. — Product Code DZJ

K201353 is an FDA 510(k) premarket notification submitted by Centermed, Inc. for the device "CenterMed Patient Matched Assisted Surgical Planning (ASP) System". The FDA issued a decision of Substantially Equivalent on June 28, 2021. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. Centermed, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2021
Date Received
May 21, 2020
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 Centermed, Inc.

  • K211614 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (August 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)
  • K220648 — OMF ASP System (August 11, 2022)
  • K212570 — OsteoPlan System (February 11, 2022)
  • K193301 — coDiagnostiX (June 21, 2021)

FDA data resources