Cleared Traditional

K230540 - Patient Specific Planning Solution™ 3D Bone Models (FDA 510(k) Clearance)

K230540 · Biomet Manufacturing Corp · Radiology device

Jul 2023

Decision

148d

Days

Class 2

Risk

K230540 is an FDA 510(k) clearance for the Patient Specific Planning Solution™ 3D Bone Models. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K230540 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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