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FDA 510(k)

COLLARLESS TAPERED STEM HIP PROSTH. DEV

K-Number: K811738 · 1981-07-20

ApplicantBiomet, Inc.
Decision Date1981-07-20
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLLARLESS TAPERED STEM HIP PROSTH. DEV is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811738. 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 COLLARLESS TAPERED STEM HIP PROSTH. DEV?

COLLARLESS TAPERED STEM HIP PROSTH. DEV is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Biomet, Inc.. The 510(k) number is K811738.

When did COLLARLESS TAPERED STEM HIP PROSTH. DEV receive FDA 510(k) clearance?

COLLARLESS TAPERED STEM HIP PROSTH. DEV received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811738.

Who is the listed applicant for COLLARLESS TAPERED STEM HIP PROSTH. DEV?

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 COLLARLESS TAPERED STEM HIP PROSTH. DEV?

The FDA product code for COLLARLESS TAPERED STEM HIP PROSTH. DEV is KWL.

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Other records listing Biomet, Inc. as applicant

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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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