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FDA 510(k)

TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS

K-Number: K053340 · 2006-02-27

ApplicantZimmer Trabecular
Decision Date2006-02-27
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular. It received FDA 510(k) clearance on 2006-02-27 under 510(k) number K053340. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS?

TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS is a medical device that received FDA 510(k) clearance on 2006-02-27. The listed applicant is Zimmer Trabecular. The 510(k) number is K053340.

When did TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS receive FDA 510(k) clearance?

TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS received FDA 510(k) clearance on 2006-02-27, under 510(k) number K053340.

Who is the listed applicant for TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS?

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

What is the FDA product code for TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS?

The FDA product code for TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS is MBH.

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Other records listing Zimmer Trabecular 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.

K061155VISTA P VERTEBRAL BODY REPLACEMENT SYSTEMK061067TRABECULAR METAL ACETABULAR AUGMENTSK052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEMK051756MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZK050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMK050937TRABECULAR METAL ACETABULAR REVISION SHELLS

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Related Devices (Code: MBH)

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.

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

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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