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FDA 510(k)

CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY

K-Number: K110836 · 2011-10-07

ApplicantZimmer GmbH
Decision Date2011-10-07
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2011-10-07 under 510(k) number K110836. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY?

CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2011-10-07. The listed applicant is Zimmer GmbH. The 510(k) number is K110836.

When did CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY receive FDA 510(k) clearance?

CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY received FDA 510(k) clearance on 2011-10-07, under 510(k) number K110836.

Who is the listed applicant for CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY?

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

What is the FDA product code for CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY?

The FDA product code for CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY is KWA.

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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