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FDA 510(k)

DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER

K-Number: K983491 · 1998-12-02

ApplicantDePuy Orthopaedics, Inc.
Decision Date1998-12-02
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 1998-12-02 under 510(k) number K983491. 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 DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER?

DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER is a medical device that received FDA 510(k) clearance on 1998-12-02. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K983491.

When did DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER receive FDA 510(k) clearance?

DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER received FDA 510(k) clearance on 1998-12-02, under 510(k) number K983491.

Who is the listed applicant for DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER?

The FDA product code for DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER is LPH.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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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

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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