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510(k) K242263

TECHFIT DISRP® System by Techfit Digital Surgery, Inc. — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2024
Date Received
August 1, 2024
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 Techfit Digital Surgery, Inc.

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  • K230276 — TECHFIT DISRP® System (June 23, 2023)
  • K222577 — TECHFIT Diagnostic Models (January 6, 2023)
  • K220199 — AFFINITY Proximal Tibia System (March 21, 2022)

Other clearances for product code DZJ

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  • 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)
  • K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (June 28, 2021)
  • K193301 — coDiagnostiX (June 21, 2021)
  • K210347 — VSP System (April 26, 2021)