Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Versacem Acetabular Shell and Double Mobility HC Liners

K-Number: K241767 · 2025-03-06

ApplicantMedacta International S.A.
Decision Date2025-03-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Versacem Acetabular Shell and Double Mobility HC Liners is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-03-06 under approval number K241767. 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 Versacem Acetabular Shell and Double Mobility HC Liners?

Versacem Acetabular Shell and Double Mobility HC Liners is a medical device that received FDA 510(k) clearance on 2025-03-06. It is manufactured by Medacta International S.A.. The 510(k) number is K241767.

When was Versacem Acetabular Shell and Double Mobility HC Liners approved by the FDA?

Versacem Acetabular Shell and Double Mobility HC Liners received FDA 510(k) clearance on 2025-03-06, under approval number K241767.

What company makes Versacem Acetabular Shell and Double Mobility HC Liners?

Versacem Acetabular Shell and Double Mobility HC Liners is manufactured by Medacta International S.A..

What is the FDA product code for Versacem Acetabular Shell and Double Mobility HC Liners?

The FDA product code for Versacem Acetabular Shell and Double Mobility HC Liners is LZO.

Related Clinical Trials

NCT05591859 Restoration Anatomic Acetabular Shell Revision Study WITHDRAWN NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07567989 Effectiveness of Home-Based Exercise and Brain Stimulation for Reducing Fatigue in Patients With Multiple Sclerosis ENROLLING_BY_INVITATION NCT04090359 Dual Mobility Acetabular Cups in Revision TJA RECRUITING NCT06671171 Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial COMPLETED

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

View all 146 devices →

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.

↑