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FDA 510(k)

MUELLER CURVED STEM HEMI-PROSTHESIS

K-Number: K853662 · 1985-09-24

ApplicantProtek, Inc.
Decision Date1985-09-24
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MUELLER CURVED STEM HEMI-PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1985-09-24 under 510(k) number K853662. 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 MUELLER CURVED STEM HEMI-PROSTHESIS?

MUELLER CURVED STEM HEMI-PROSTHESIS is a medical device that received FDA 510(k) clearance on 1985-09-24. The listed applicant is Protek, Inc.. The 510(k) number is K853662.

When did MUELLER CURVED STEM HEMI-PROSTHESIS receive FDA 510(k) clearance?

MUELLER CURVED STEM HEMI-PROSTHESIS received FDA 510(k) clearance on 1985-09-24, under 510(k) number K853662.

Who is the listed applicant for MUELLER CURVED STEM HEMI-PROSTHESIS?

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

What is the FDA product code for MUELLER CURVED STEM HEMI-PROSTHESIS?

The FDA product code for MUELLER CURVED STEM HEMI-PROSTHESIS is KWL.

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Other records listing Protek, 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.

K893785ARC-2F ACETABULAR CUPK893959P.S.A. FEMORAL HIP PROSTHESISK892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURK883794RESUBMITTED CLW ACETABULAR CUP W/SULMESHK884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICK884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

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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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