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FDA 510(k)

FEMORAL HEMI-HIP PROSTHESES

K-Number: K855228 · 1986-02-11

ApplicantOrthopaedic Device Corp.
Decision Date1986-02-11
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FEMORAL HEMI-HIP PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Device Corp.. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K855228. 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 FEMORAL HEMI-HIP PROSTHESES?

FEMORAL HEMI-HIP PROSTHESES is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is Orthopaedic Device Corp.. The 510(k) number is K855228.

When did FEMORAL HEMI-HIP PROSTHESES receive FDA 510(k) clearance?

FEMORAL HEMI-HIP PROSTHESES received FDA 510(k) clearance on 1986-02-11, under 510(k) number K855228.

Who is the listed applicant for FEMORAL HEMI-HIP PROSTHESES?

The FDA 510(k) record lists Orthopaedic Device Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMORAL HEMI-HIP PROSTHESES?

The FDA product code for FEMORAL HEMI-HIP PROSTHESES 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 Orthopaedic Device Corp. 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.

K870234P.T.H. METAL-BACKED ACETABULAR CUPK862460FEMORAL HEMI-HIP PROSTHESISK863343SUPERFIXATION(TM)

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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