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FDA 510(k)

BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT

K-Number: K894604 · 1989-11-17

ApplicantBiopro, Inc.
Decision Date1989-11-17
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K894604. The device is classified under product code KXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT?

BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Biopro, Inc.. The 510(k) number is K894604.

When did BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT receive FDA 510(k) clearance?

BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT received FDA 510(k) clearance on 1989-11-17, under 510(k) number K894604.

Who is the listed applicant for BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT?

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 PROXIMAL FEMORAL ARTICULAR REPLACEMENT?

The FDA product code for BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT is KXA.

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Other records listing Biopro, 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 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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