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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K230540
Device Name Patient Specific Planning Solution™ 3D Bone Models
Applicant
Biomet Manufacturing Corp
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact Katherine Choi
Correspondent
Biomet Manufacturing Corp
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact Katherine Choi
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/27/2023
Decision Date 07/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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