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FDA 510(k)

TRABECULAR METAL TIBIAL CONE AUGMENTS

K-Number: K102896 · 2010-12-13

ApplicantZimmer Trabecular Metal Technology
Decision Date2010-12-13
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRABECULAR METAL TIBIAL CONE AUGMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular Metal Technology. It received FDA 510(k) clearance on 2010-12-13 under 510(k) number K102896. 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 CONE AUGMENTS?

TRABECULAR METAL TIBIAL CONE AUGMENTS is a medical device that received FDA 510(k) clearance on 2010-12-13. The listed applicant is Zimmer Trabecular Metal Technology. The 510(k) number is K102896.

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

TRABECULAR METAL TIBIAL CONE AUGMENTS received FDA 510(k) clearance on 2010-12-13, under 510(k) number K102896.

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

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

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

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

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Other records listing Zimmer Trabecular Metal Technology 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.

K123602TM ARDIS INTERBODY SYSTEM INSERTERK120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIALK113561TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATIONK111983VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXXK103033TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXXK093127TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET

View all 10 devices →

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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