Cleared Traditional

CORIOGRAPH Pre-Op Planning and Modeling Services

K250921 · Blue Belt Technologies, Inc. · Orthopedic
Jun 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250921 is an FDA 510(k) clearance for the CORIOGRAPH Pre-Op Planning and Modeling Services, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 25, 2025, 90 days after receiving the submission on March 27, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250921 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2025
Decision Date June 25, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code PBF — Orthopaedic Surgical Planning And Instrument Guides
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030
Definition 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.