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FDA 510(k)

BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE

K-Number: K890044 · 1989-11-06

ApplicantBiopro, Inc.
Decision Date1989-11-06
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 1989-11-06 under 510(k) number K890044. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE?

BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Biopro, Inc.. The 510(k) number is K890044.

When did BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE receive FDA 510(k) clearance?

BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE received FDA 510(k) clearance on 1989-11-06, under 510(k) number K890044.

Who is the listed applicant for BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE?

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 ANATOMIC UNICOMPARTMENTAL KNEE?

The FDA product code for BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE is HRY.

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Other records listing Biopro, Inc. as applicant

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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: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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