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FDA 510(k)

MALLORY HEAD MODULAR CALCAR

K-Number: K001660 · 2000-06-14

ApplicantBiomet Orthopedics, Inc.
Decision Date2000-06-14
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MALLORY HEAD MODULAR CALCAR is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2000-06-14 under 510(k) number K001660. 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 MALLORY HEAD MODULAR CALCAR?

MALLORY HEAD MODULAR CALCAR is a medical device that received FDA 510(k) clearance on 2000-06-14. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K001660.

When did MALLORY HEAD MODULAR CALCAR receive FDA 510(k) clearance?

MALLORY HEAD MODULAR CALCAR received FDA 510(k) clearance on 2000-06-14, under 510(k) number K001660.

Who is the listed applicant for MALLORY HEAD MODULAR CALCAR?

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

What is the FDA product code for MALLORY HEAD MODULAR CALCAR?

The FDA product code for MALLORY HEAD MODULAR CALCAR is LPH.

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Other records listing Biomet Orthopedics, Inc. as applicant

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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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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