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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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K241767.

When did Versacem Acetabular Shell and Double Mobility HC Liners receive FDA 510(k) clearance?

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

Who is the listed applicant for Versacem Acetabular Shell and Double Mobility HC Liners?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07207005Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip ArthroplastyRECRUITING

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Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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