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FDA 510(k)

TRABECULAR METAL KNEE SYSTEM AUGMENTS

K-Number: K040487 · 2004-12-21

ApplicantImplex Corp.
Decision Date2004-12-21
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRABECULAR METAL KNEE SYSTEM AUGMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2004-12-21 under 510(k) number K040487. 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 KNEE SYSTEM AUGMENTS?

TRABECULAR METAL KNEE SYSTEM AUGMENTS is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Implex Corp.. The 510(k) number is K040487.

When did TRABECULAR METAL KNEE SYSTEM AUGMENTS receive FDA 510(k) clearance?

TRABECULAR METAL KNEE SYSTEM AUGMENTS received FDA 510(k) clearance on 2004-12-21, under 510(k) number K040487.

Who is the listed applicant for TRABECULAR METAL KNEE SYSTEM AUGMENTS?

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

What is the FDA product code for TRABECULAR METAL KNEE SYSTEM AUGMENTS?

The FDA product code for TRABECULAR METAL KNEE SYSTEM AUGMENTS is MBH.

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Other records listing Implex 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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTSK033384THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

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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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