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FDA 510(k)

Legend Acetabular Liners

K-Number: K173951 · 2018-05-30

ApplicantOrtho Development Corporation
Decision Date2018-05-30
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Legend Acetabular Liners is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K173951. 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 Liners?

Legend Acetabular Liners is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is Ortho Development Corporation. The 510(k) number is K173951.

When did Legend Acetabular Liners receive FDA 510(k) clearance?

Legend Acetabular Liners received FDA 510(k) clearance on 2018-05-30, under 510(k) number K173951.

Who is the listed applicant for Legend Acetabular Liners?

The FDA 510(k) record lists Ortho Development Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legend Acetabular Liners?

The FDA product code for Legend Acetabular Liners is LPH.

Other records listing Ortho Development Corporation as applicant

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.

K253161Balanced Knee System TriMax Porous Femoral ComponentsK251052Trivicta® Hip StemK242984BKS Revision SystemK242833Legend® Acetabular ShellK233758Trivicta™ Hip StemK233093Balanced Knee® System TriMax PS Plus Tibial Insert

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Related Devices (Code: LPH)

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.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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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