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FDA 510(k)

ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS

K-Number: K021878 · 2003-03-04

ApplicantEska America Corp.
Decision Date2003-03-04
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Eska America Corp.. It received FDA 510(k) clearance on 2003-03-04 under 510(k) number K021878. 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 ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS?

ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS is a medical device that received FDA 510(k) clearance on 2003-03-04. The listed applicant is Eska America Corp.. The 510(k) number is K021878.

When did ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS receive FDA 510(k) clearance?

ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS received FDA 510(k) clearance on 2003-03-04, under 510(k) number K021878.

Who is the listed applicant for ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS?

The FDA 510(k) record lists Eska America Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS?

The FDA product code for ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS is LPH.

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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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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