FDA 510(k)

EPOCH HIP PROSTHESIS, MODEL 4075 SERIES

K-Number: K014070 · 2002-07-30

Decision Date2002-07-30

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EPOCH HIP PROSTHESIS, MODEL 4075 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2002-07-30 under 510(k) number K014070. 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 EPOCH HIP PROSTHESIS, MODEL 4075 SERIES?

EPOCH HIP PROSTHESIS, MODEL 4075 SERIES is a medical device that received FDA 510(k) clearance on 2002-07-30. The listed applicant is Zimmer, Inc.. The 510(k) number is K014070.

When did EPOCH HIP PROSTHESIS, MODEL 4075 SERIES receive FDA 510(k) clearance?

EPOCH HIP PROSTHESIS, MODEL 4075 SERIES received FDA 510(k) clearance on 2002-07-30, under 510(k) number K014070.

Who is the listed applicant for EPOCH HIP PROSTHESIS, MODEL 4075 SERIES?

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

What is the FDA product code for EPOCH HIP PROSTHESIS, MODEL 4075 SERIES?

The FDA product code for EPOCH HIP PROSTHESIS, MODEL 4075 SERIES is LPH.

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® 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.