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FDA 510(k)

CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT

K-Number: K092803 · 2009-12-23

ApplicantCardo Medical Corp.
Decision Date2009-12-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT 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 2009-12-23 under 510(k) number K092803. 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 ALIGN 360 MEDIALIZED PATELLA COMPONENT?

CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Cardo Medical Corp.. The 510(k) number is K092803.

When did CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT receive FDA 510(k) clearance?

CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT received FDA 510(k) clearance on 2009-12-23, under 510(k) number K092803.

Who is the listed applicant for CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT?

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 CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT?

The FDA product code for CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT 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 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.

K094045MODIFICAITON TO: CARDO MEDICAL HIP SYSTEMK091396CARDO MEDICAL ANTERIOR CERVICAL PLATE 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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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