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FDA 510(k)

PROSTHESIS, HIP FEMORAL COMPONENT METAL

K-Number: K803191 · 1981-01-23

ApplicantOsteonics Corp.
Decision Date1981-01-23
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROSTHESIS, HIP FEMORAL COMPONENT METAL is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1981-01-23 under 510(k) number K803191. 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 PROSTHESIS, HIP FEMORAL COMPONENT METAL?

PROSTHESIS, HIP FEMORAL COMPONENT METAL is a medical device that received FDA 510(k) clearance on 1981-01-23. The listed applicant is Osteonics Corp.. The 510(k) number is K803191.

When did PROSTHESIS, HIP FEMORAL COMPONENT METAL receive FDA 510(k) clearance?

PROSTHESIS, HIP FEMORAL COMPONENT METAL received FDA 510(k) clearance on 1981-01-23, under 510(k) number K803191.

Who is the listed applicant for PROSTHESIS, HIP FEMORAL COMPONENT METAL?

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

What is the FDA product code for PROSTHESIS, HIP FEMORAL COMPONENT METAL?

The FDA product code for PROSTHESIS, HIP FEMORAL COMPONENT METAL is KWL.

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Other records listing Osteonics 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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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