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FDA 510(k)

METAL KNEE & HIP PROSTHESIS

K-Number: K823051 · 1982-12-03

ApplicantZimmer, Inc.
Decision Date1982-12-03
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAL KNEE & HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K823051. 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 METAL KNEE & HIP PROSTHESIS?

METAL KNEE & HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Zimmer, Inc.. The 510(k) number is K823051.

When did METAL KNEE & HIP PROSTHESIS receive FDA 510(k) clearance?

METAL KNEE & HIP PROSTHESIS received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823051.

Who is the listed applicant for METAL KNEE & HIP PROSTHESIS?

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

What is the FDA product code for METAL KNEE & HIP PROSTHESIS?

The FDA product code for METAL KNEE & HIP PROSTHESIS is KWL.

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Other records listing Zimmer, 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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