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FDA 510(k)

MOORE HIP PROSTHESIS, PMMA COATED

K-Number: K811416 · 1981-08-12

ApplicantZimmer, Inc.
Decision Date1981-08-12
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOORE HIP PROSTHESIS, PMMA COATED is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1981-08-12 under 510(k) number K811416. 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 MOORE HIP PROSTHESIS, PMMA COATED?

MOORE HIP PROSTHESIS, PMMA COATED is a medical device that received FDA 510(k) clearance on 1981-08-12. The listed applicant is Zimmer, Inc.. The 510(k) number is K811416.

When did MOORE HIP PROSTHESIS, PMMA COATED receive FDA 510(k) clearance?

MOORE HIP PROSTHESIS, PMMA COATED received FDA 510(k) clearance on 1981-08-12, under 510(k) number K811416.

Who is the listed applicant for MOORE HIP PROSTHESIS, PMMA COATED?

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 MOORE HIP PROSTHESIS, PMMA COATED?

The FDA product code for MOORE HIP PROSTHESIS, PMMA COATED is KWL.

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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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