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510(k) K212237

3D-Cut by 3D-Side S.A. — Product Code PBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2021
Date Received
July 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopaedic Surgical Planning And Instrument Guides
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

Other clearances by 3D-Side S.A.

  • K243509 — Archer PSI System (May 12, 2025)
  • K221432 — Customize (August 3, 2022)
  • K213779 — Customize (March 16, 2022)

Other clearances for product code PBF

  • K250711 — VSP Orthopedics System (December 5, 2025)
  • K242603 — MyPAO SA guides (November 19, 2025)
  • K251709 — MedCAD® AccuStride™ System (November 4, 2025)
  • K250394 — Fine TTO™ (October 21, 2025)
  • K250767 — Newclip Patient-matched instrumentation non sterile PSI (October 1, 2025)
  • K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services (June 25, 2025)
  • K241811 — MedCAD® AccuStride™ System (March 13, 2025)
  • K243912 — Newclip Patient-matched instrumentation non sterile PSI (February 13, 2025)
  • K240415 — Newclip Patient-matched instrumentation non sterile PSI (November 7, 2024)
  • K240113 — CORIOGRAPH Knee Pre-Op Plan (March 18, 2024)