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FDA 510(k)

CARDO MEDICAL CERAMIC HIP SYSTEM

K-Number: K100008 · 2010-05-18

ApplicantCardo Medical, Inc.
Decision Date2010-05-18
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CARDO MEDICAL CERAMIC HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardo Medical, Inc.. It received FDA 510(k) clearance on 2010-05-18 under 510(k) number K100008. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDO MEDICAL CERAMIC HIP SYSTEM?

CARDO MEDICAL CERAMIC HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-18. The listed applicant is Cardo Medical, Inc.. The 510(k) number is K100008.

When did CARDO MEDICAL CERAMIC HIP SYSTEM receive FDA 510(k) clearance?

CARDO MEDICAL CERAMIC HIP SYSTEM received FDA 510(k) clearance on 2010-05-18, under 510(k) number K100008.

Who is the listed applicant for CARDO MEDICAL CERAMIC HIP SYSTEM?

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

What is the FDA product code for CARDO MEDICAL CERAMIC HIP SYSTEM?

The FDA product code for CARDO MEDICAL CERAMIC HIP SYSTEM is LZO.

Related Clinical Trials

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Other records listing Cardo Medical, 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.

K101032CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX

Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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