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FDA 510(k)

BIOPRO TARA FEMORAL RESURFACING COMPONENT

K-Number: K043542 · 2005-05-18

ApplicantBiopro, Inc.
Decision Date2005-05-18
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO TARA FEMORAL RESURFACING COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 2005-05-18 under 510(k) number K043542. 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 BIOPRO TARA FEMORAL RESURFACING COMPONENT?

BIOPRO TARA FEMORAL RESURFACING COMPONENT is a medical device that received FDA 510(k) clearance on 2005-05-18. The listed applicant is Biopro, Inc.. The 510(k) number is K043542.

When did BIOPRO TARA FEMORAL RESURFACING COMPONENT receive FDA 510(k) clearance?

BIOPRO TARA FEMORAL RESURFACING COMPONENT received FDA 510(k) clearance on 2005-05-18, under 510(k) number K043542.

Who is the listed applicant for BIOPRO TARA FEMORAL RESURFACING COMPONENT?

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

What is the FDA product code for BIOPRO TARA FEMORAL RESURFACING COMPONENT?

The FDA product code for BIOPRO TARA FEMORAL RESURFACING COMPONENT is KXA.

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Other records listing Biopro, Inc. 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.

K163627Shotel Ankle Arthrodesis Nail SystemK162674BioPro Foot Plating SystemsK132510BIOPRO - INFINITY PLATE ANCHOR SYSTEMK130298BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEMK121973BIOPRO HEMI-EDGE TOE SYSTEMK100761BIOPRO POLAR HEAD

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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.K070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSZimmer GmbHK062960CONSERVE FEMORAL RESURFACING COMPONENTWrightmedicaltechnologyinc

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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