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510(k) K240415

Newclip Patient-matched instrumentation non sterile PSI by Newclip Technics — Product Code PBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2024
Date Received
February 12, 2024
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 Newclip Technics

  • K253906 — Xpert Hand (March 11, 2026)
  • K250767 — Newclip Patient-matched instrumentation non sterile PSI (October 1, 2025)
  • K250155 — Xpert Knee (April 23, 2025)
  • K243912 — Newclip Patient-matched instrumentation non sterile PSI (February 13, 2025)
  • K241539 — Activmotion S (July 30, 2024)
  • K221615 — Newclip Patient-matched instrumentation non sterile PSI (October 25, 2023)
  • K221395 — Footmotion Plating System (July 1, 2022)
  • K202803 — Activmotion S DTO (December 16, 2021)
  • K213214 — Xpert Wrist (November 24, 2021)
  • K202307 — Activ Fuse (November 17, 2020)

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)
  • K240113 — CORIOGRAPH Knee Pre-Op Plan (March 18, 2024)
  • K240066 — Fine Osteotomy™ (February 9, 2024)