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FDA 510(k)

NEW JERSEY FEMORAL STEM

K-Number: K842234 · 1984-07-20

ApplicantEndomedics, Inc.
Decision Date1984-07-20
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEW JERSEY FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Endomedics, Inc.. It received FDA 510(k) clearance on 1984-07-20 under 510(k) number K842234. 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 NEW JERSEY FEMORAL STEM?

NEW JERSEY FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1984-07-20. The listed applicant is Endomedics, Inc.. The 510(k) number is K842234.

When did NEW JERSEY FEMORAL STEM receive FDA 510(k) clearance?

NEW JERSEY FEMORAL STEM received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842234.

Who is the listed applicant for NEW JERSEY FEMORAL STEM?

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

What is the FDA product code for NEW JERSEY FEMORAL STEM?

The FDA product code for NEW JERSEY FEMORAL STEM is KWL.

Related Clinical Trials

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.

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Other records listing Endomedics, 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.

K831792SELF-ALIGNING ACETABULAR COMPONENTK842233NEW JERSEY FEMORAL RESURFACING COMPONENTK842202NEW JERSEY ACETABULAR COMPONENT &

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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