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FDA 510(k)

ceramys™ femoral head system

K-Number: K241483 · 2025-02-07

ApplicantEncore Medical L.P.
Decision Date2025-02-07
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ceramys™ femoral head system is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2025-02-07 under approval number K241483. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ceramys™ femoral head system?

ceramys™ femoral head system is a medical device that received FDA 510(k) clearance on 2025-02-07. It is manufactured by Encore Medical L.P.. The 510(k) number is K241483.

When was ceramys™ femoral head system approved by the FDA?

ceramys™ femoral head system received FDA 510(k) clearance on 2025-02-07, under approval number K241483.

What company makes ceramys™ femoral head system?

ceramys™ femoral head system is manufactured by Encore Medical L.P..

What is the FDA product code for ceramys™ femoral head system?

The FDA product code for ceramys™ femoral head system is LZO.

Related Clinical Trials

NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING NCT05523635 Post Market Clinical Evaluation of Gamma 4 COMPLETED NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT06368700 The HYALEX Pivotal Study RECRUITING

Other Devices by Encore Medical L.P.

K162024AltiVate Anatomic Shoulder System K161610EXPRT Revision Hip System K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) K160342EMPOWR PS Knee System K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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.

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