Cleared Traditional

CORIOGRAPH Pre-Op Planning and Modeling Services

K242272 · Blue Belt Technologies, Inc. · Orthopedic

Nov 2024

Decision

106d

Days

—

Risk

About This 510(k) Submission

K242272 is an FDA 510(k) clearance for the CORIOGRAPH Pre-Op Planning and Modeling Services, submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 15, 2024, 106 days after receiving the submission on August 1, 2024. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number	K242272 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2024
Decision Date	November 15, 2024
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF