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FDA 510(k)

PERFECTA FEMORAL STEM

K-Number: K031402 · 2004-11-22

ApplicantWrightmedicaltechnologyinc
Decision Date2004-11-22
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFECTA FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K031402. 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 PERFECTA FEMORAL STEM?

PERFECTA FEMORAL STEM is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K031402.

When did PERFECTA FEMORAL STEM receive FDA 510(k) clearance?

PERFECTA FEMORAL STEM received FDA 510(k) clearance on 2004-11-22, under 510(k) number K031402.

Who is the listed applicant for PERFECTA FEMORAL STEM?

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

What is the FDA product code for PERFECTA FEMORAL STEM?

The FDA product code for PERFECTA FEMORAL STEM is LPH.

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Related Devices (Code: LPH)

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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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