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FDA 510(k)

M-COR HIP REPLACEMENT SYSTEM

K-Number: K053417 · 2006-07-20

ApplicantPortland Orthopaedics Pty. , Ltd.
Decision Date2006-07-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M-COR HIP REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Portland Orthopaedics Pty. , Ltd.. It received FDA 510(k) clearance on 2006-07-20 under 510(k) number K053417. 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 M-COR HIP REPLACEMENT SYSTEM?

M-COR HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-20. The listed applicant is Portland Orthopaedics Pty. , Ltd.. The 510(k) number is K053417.

When did M-COR HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

M-COR HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 2006-07-20, under 510(k) number K053417.

Who is the listed applicant for M-COR HIP REPLACEMENT SYSTEM?

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

What is the FDA product code for M-COR HIP REPLACEMENT SYSTEM?

The FDA product code for M-COR HIP REPLACEMENT SYSTEM is LPH.

Related Clinical Trials

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.

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Other records listing Portland Orthopaedics Pty. , Ltd. 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.

K061564PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEADK051844EQUATOR PLUS ACETABULAR CUP SYSTEMK032641MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEMK992815THE MARGRON HIP REPLACEMENT SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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