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FDA 510(k)

Legend® Acetabular Shell

K-Number: K242833 · 2024-10-11

ApplicantOrtho Development Corp.
Decision Date2024-10-11
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Legend® Acetabular Shell is a medical device manufactured by Ortho Development Corp.. It received FDA 510(k) clearance on 2024-10-11 under approval number K242833. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Legend® Acetabular Shell?

Legend® Acetabular Shell is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by Ortho Development Corp.. The 510(k) number is K242833.

When was Legend® Acetabular Shell approved by the FDA?

Legend® Acetabular Shell received FDA 510(k) clearance on 2024-10-11, under approval number K242833.

What company makes Legend® Acetabular Shell?

Legend® Acetabular Shell is manufactured by Ortho Development Corp..

What is the FDA product code for Legend® Acetabular Shell?

The FDA product code for Legend® Acetabular Shell is LPH.

Related Clinical Trials

NCT05591859 Restoration Anatomic Acetabular Shell Revision Study WITHDRAWN NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT02999009 Trident II Tritanium Acetabular Shell Outcomes Study ACTIVE_NOT_RECRUITING

Other Devices by Ortho Development Corp.

K242984BKS Revision System K233758Trivicta™ Hip Stem K253161Balanced Knee System TriMax Porous Femoral Components K251052Trivicta® Hip Stem

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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