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FDA 510(k)

MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM

K-Number: K094045 · 2010-04-22

ApplicantCardo Medical Corp.
Decision Date2010-04-22
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardo Medical Corp.. It received FDA 510(k) clearance on 2010-04-22 under 510(k) number K094045. 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 MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM?

MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Cardo Medical Corp.. The 510(k) number is K094045.

When did MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM receive FDA 510(k) clearance?

MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM received FDA 510(k) clearance on 2010-04-22, under 510(k) number K094045.

Who is the listed applicant for MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM?

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

What is the FDA product code for MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM?

The FDA product code for MODIFICAITON TO: CARDO MEDICAL HIP 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 Cardo Medical Corp. 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.

K092803CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENTK091396CARDO MEDICAL ANTERIOR CERVICAL PLATE 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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