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510(k) K211614

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2022
Date Received
May 26, 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 Centermed, Inc.

  • K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (June 28, 2021)

Other clearances for product code PBF

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  • 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)