Cleared Traditional

CUPTIMIZE? Advanced

K231503 · DePuy Orthopaedics, Inc. · Radiology
Aug 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K231503 is an FDA 510(k) clearance for the CUPTIMIZE? Advanced, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 22, 2023, 90 days after receiving the submission on May 24, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K231503 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2023
Decision Date August 22, 2023
Days to Decision 90 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