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FDA 510(k)

MECRON MRC-HEADLESS FEMORAL COMPONENT

K-Number: K844486 · 1985-02-19

ApplicantMecron Medical Products, Inc.
Decision Date1985-02-19
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MECRON MRC-HEADLESS FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Mecron Medical Products, Inc.. It received FDA 510(k) clearance on 1985-02-19 under 510(k) number K844486. 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 MECRON MRC-HEADLESS FEMORAL COMPONENT?

MECRON MRC-HEADLESS FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1985-02-19. The listed applicant is Mecron Medical Products, Inc.. The 510(k) number is K844486.

When did MECRON MRC-HEADLESS FEMORAL COMPONENT receive FDA 510(k) clearance?

MECRON MRC-HEADLESS FEMORAL COMPONENT received FDA 510(k) clearance on 1985-02-19, under 510(k) number K844486.

Who is the listed applicant for MECRON MRC-HEADLESS FEMORAL COMPONENT?

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

What is the FDA product code for MECRON MRC-HEADLESS FEMORAL COMPONENT?

The FDA product code for MECRON MRC-HEADLESS FEMORAL COMPONENT is KWL.

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Other records listing Mecron Medical Products, 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.

K861138MASH DERMATOMEK854191MECRON UNCEMENTED STRUCTURED STEM HIPK844775EFFNER-EYE CAUTERY WITH BATTERY HANDLEK844774EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISSK844488MECRON CEMENTED STRUCTURED STEM HIP PROSTHESISK844487MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR

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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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