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FDA 510(k)

MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL

K-Number: K003429 · 2000-11-30

ApplicantBiomet, Inc.
Decision Date2000-11-30
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2000-11-30 under 510(k) number K003429. 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 MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL?

MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL is a medical device that received FDA 510(k) clearance on 2000-11-30. The listed applicant is Biomet, Inc.. The 510(k) number is K003429.

When did MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL receive FDA 510(k) clearance?

MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL received FDA 510(k) clearance on 2000-11-30, under 510(k) number K003429.

Who is the listed applicant for MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL?

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

What is the FDA product code for MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL?

The FDA product code for MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL is LPH.

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Other records listing Biomet, 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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