CUPTIMIZE Advanced
FDA 510(k) K231503 · DePuy Orthopaedics, Inc.
510(k) numberK231503
Submission
- Device name
- CUPTIMIZE Advanced
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- May 24, 2023
- Decision date
- August 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CUPTIMIZE Advanced cleared by the FDA?
CUPTIMIZE Advanced (K231503) received a 510(k) decision of Substantially Equivalent on August 22, 2023, 90 days after the submission was received.
What is the product code of K231503?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.