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FDA 510(k)

RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD

K-Number: K071053 · 2007-06-29

ApplicantBiomet, Inc.
Decision Date2007-06-29
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K071053. 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 RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD?

RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Biomet, Inc.. The 510(k) number is K071053.

When did RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD receive FDA 510(k) clearance?

RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071053.

Who is the listed applicant for RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD?

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

What is the FDA product code for RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD?

The FDA product code for RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD is KXA.

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Other records listing Biomet, Inc. as applicant

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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 COMPONENTWrightmedicaltechnologyincK070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSZimmer GmbHK062960CONSERVE 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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