FDA 510(k)

CUPTIMIZE Advanced

K-Number: K231503 · 2023-08-22

Decision Date2023-08-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CUPTIMIZE Advanced is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-08-22 under approval number K231503. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUPTIMIZE Advanced?

CUPTIMIZE Advanced is a medical device that received FDA 510(k) clearance on 2023-08-22. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K231503.

When was CUPTIMIZE Advanced approved by the FDA?

CUPTIMIZE Advanced received FDA 510(k) clearance on 2023-08-22, under approval number K231503.

What company makes CUPTIMIZE Advanced?

CUPTIMIZE Advanced is manufactured by DePuy Orthopaedics, Inc..

What is the FDA product code for CUPTIMIZE Advanced?

The FDA product code for CUPTIMIZE Advanced is LLZ.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Other Devices by DePuy Orthopaedics, Inc.

K170339Summit Hip System K192919Pinnacle Duofix HA Acetabular Cup Prosthesis K192946DePuy Corail AMT Hip Prosthesis K182301PFC SIGMA Knee System K203167DePuy Corail AMT Hip Prosthesis K202472ACTIS Duofix Hip Prosthesis

View all 13 devices →

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.