Cleared Traditional

Patient Specific Planning Solution? 3D Bone Models

K230540 · Biomet Manufacturing Corp · Radiology
Jul 2023
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K230540 is an FDA 510(k) clearance for the Patient Specific Planning Solution? 3D Bone Models, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on July 25, 2023, 148 days after receiving the submission on February 27, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K230540 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2023
Decision Date July 25, 2023
Days to Decision 148 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050