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FDA 510(k)

DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS

K-Number: K070292 · 2007-04-26

ApplicantZimmer GmbH
Decision Date2007-04-26
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2007-04-26 under 510(k) number K070292. The device is classified under product code KXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS?

DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS is a medical device that received FDA 510(k) clearance on 2007-04-26. The listed applicant is Zimmer GmbH. The 510(k) number is K070292.

When did DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS receive FDA 510(k) clearance?

DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS received FDA 510(k) clearance on 2007-04-26, under 510(k) number K070292.

Who is the listed applicant for DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS?

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 DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS?

The FDA product code for DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS is KXA.

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Related Devices (Code: KXA)

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.

K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLCK092198CORMET CEMENTLESS RESURFACING FEMORAL HEADCorin USAK082673CONSERVE PRESSFIT FEMORAL COMPONENTWrightmedicaltechnologyincK071053RECAP HA PRESS-FIT FEMORAL RESURFACING HEADBiomet, Inc.K062960CONSERVE FEMORAL RESURFACING COMPONENTWrightmedicaltechnologyincK043542BIOPRO TARA FEMORAL RESURFACING COMPONENTBiopro, Inc.

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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