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FDA 510(k)

NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL

K-Number: K120990 · 2012-06-29

ApplicantZimmer Trabecular Metal Technology
Decision Date2012-06-29
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL 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 2012-06-29 under 510(k) number K120990. 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 NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL?

NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Zimmer Trabecular Metal Technology. The 510(k) number is K120990.

When did NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL receive FDA 510(k) clearance?

NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL received FDA 510(k) clearance on 2012-06-29, under 510(k) number K120990.

Who is the listed applicant for NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL?

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 NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL?

The FDA product code for NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL 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 INSERTERK113561TM 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-XXXXXK102896TRABECULAR METAL TIBIAL CONE AUGMENTSK093127TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET

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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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