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FDA 510(k)

CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX

K-Number: K101032 · 2010-07-08

ApplicantCardo Medical, Inc.
Decision Date2010-07-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX 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 2010-07-08 under 510(k) number K101032. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX?

CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX is a medical device that received FDA 510(k) clearance on 2010-07-08. The listed applicant is Cardo Medical, Inc.. The 510(k) number is K101032.

When did CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX receive FDA 510(k) clearance?

CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX received FDA 510(k) clearance on 2010-07-08, under 510(k) number K101032.

Who is the listed applicant for CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX?

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 FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX?

The FDA product code for CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX is JWH.

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, 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.

K100008CARDO MEDICAL CERAMIC HIP SYSTEM

Related Devices (Code: JWH)

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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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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