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510(k) K242263

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

K242263 is an FDA 510(k) premarket notification submitted by Techfit Digital Surgery, Inc. for the device "TECHFIT DISRP® System". The FDA issued a decision of Substantially Equivalent on December 11, 2024. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. Techfit Digital Surgery, Inc. has at least 4 other 510(k) clearances on record.

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.

  • K250297 — TECHFIT Patient-Specific Cranial System (October 27, 2025)
  • 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

  • K261826 — VSP System (Titanium Palatal Splint) (June 3, 2026)
  • K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (February 21, 2025)
  • 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)

FDA data resources