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FDA 510(k)

BROOKER BIO-GROOVE FEMORAL COMPONENT

K-Number: K864085 · 1987-01-28

ApplicantBiomet, Inc.
Decision Date1987-01-28
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BROOKER BIO-GROOVE FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1987-01-28 under 510(k) number K864085. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BROOKER BIO-GROOVE FEMORAL COMPONENT?

BROOKER BIO-GROOVE FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1987-01-28. The listed applicant is Biomet, Inc.. The 510(k) number is K864085.

When did BROOKER BIO-GROOVE FEMORAL COMPONENT receive FDA 510(k) clearance?

BROOKER BIO-GROOVE FEMORAL COMPONENT received FDA 510(k) clearance on 1987-01-28, under 510(k) number K864085.

Who is the listed applicant for BROOKER BIO-GROOVE FEMORAL COMPONENT?

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 BROOKER BIO-GROOVE FEMORAL COMPONENT?

The FDA product code for BROOKER BIO-GROOVE FEMORAL COMPONENT is KWL.

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Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

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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