CORIOGRAPH Pre-Op Planning and Modeling Services
K-Number: K250921 · 2025-06-25
ApplicantBlue Belt Technologies, Inc.
Decision Date2025-06-25
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CORIOGRAPH Pre-Op Planning and Modeling Services is a medical device manufactured by Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2025-06-25 under approval number K250921. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CORIOGRAPH Pre-Op Planning and Modeling Services?
CORIOGRAPH Pre-Op Planning and Modeling Services is a medical device that received FDA 510(k) clearance on 2025-06-25. It is manufactured by Blue Belt Technologies, Inc.. The 510(k) number is K250921.
When was CORIOGRAPH Pre-Op Planning and Modeling Services approved by the FDA?
CORIOGRAPH Pre-Op Planning and Modeling Services received FDA 510(k) clearance on 2025-06-25, under approval number K250921.
What company makes CORIOGRAPH Pre-Op Planning and Modeling Services?
CORIOGRAPH Pre-Op Planning and Modeling Services is manufactured by Blue Belt Technologies, Inc..
What is the FDA product code for CORIOGRAPH Pre-Op Planning and Modeling Services?
The FDA product code for CORIOGRAPH Pre-Op Planning and Modeling Services is PBF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.