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FDA 510(k)

EVOLUTION HIP SYSTEM

K-Number: K896105 · 1989-12-29

ApplicantDow Corning Wright
Decision Date1989-12-29
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EVOLUTION HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1989-12-29 under 510(k) number K896105. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EVOLUTION HIP SYSTEM?

EVOLUTION HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-29. The listed applicant is Dow Corning Wright. The 510(k) number is K896105.

When did EVOLUTION HIP SYSTEM receive FDA 510(k) clearance?

EVOLUTION HIP SYSTEM received FDA 510(k) clearance on 1989-12-29, under 510(k) number K896105.

Who is the listed applicant for EVOLUTION HIP SYSTEM?

The FDA 510(k) record lists Dow Corning Wright as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOLUTION HIP SYSTEM?

The FDA product code for EVOLUTION HIP SYSTEM is KWL.

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Other records listing Dow Corning Wright 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.

K932210ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENTK932911ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENTK934354LACEY ALL POLYETHYLENE TIBIAL COMPONENTK932222SLT FEMORAL HEADK932858ORTHOLOC ADVANTIM TIBIAL BASE COMPONENTK930228ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE

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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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