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FDA 510(k)

PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT

K-Number: K915868 · 1992-03-23

ApplicantOrthomet, Inc.
Decision Date1992-03-23
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1992-03-23 under 510(k) number K915868. 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 PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT?

PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT is a medical device that received FDA 510(k) clearance on 1992-03-23. The listed applicant is Orthomet, Inc.. The 510(k) number is K915868.

When did PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT receive FDA 510(k) clearance?

PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT received FDA 510(k) clearance on 1992-03-23, under 510(k) number K915868.

Who is the listed applicant for PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT?

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

What is the FDA product code for PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT?

The FDA product code for PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT is KWL.

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Other records listing Orthomet, 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

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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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