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FDA 510(k)

Escalade Legend Acetabular Shell

K-Number: K161080 · 2016-05-17

ApplicantOrtho Development Corporation
Decision Date2016-05-17
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Escalade Legend Acetabular Shell 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 2016-05-17 under 510(k) number K161080. 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 Escalade Legend Acetabular Shell?

Escalade Legend Acetabular Shell is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Ortho Development Corporation. The 510(k) number is K161080.

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

Escalade Legend Acetabular Shell received FDA 510(k) clearance on 2016-05-17, under 510(k) number K161080.

Who is the listed applicant for Escalade Legend Acetabular Shell?

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 Escalade Legend Acetabular Shell?

The FDA product code for Escalade Legend Acetabular Shell 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.

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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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