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FDA 510(k)

OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE

K-Number: K984585 · 1999-02-24

ApplicantOsteonics Corp.
Decision Date1999-02-24
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1999-02-24 under 510(k) number K984585. 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 OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE?

OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE is a medical device that received FDA 510(k) clearance on 1999-02-24. The listed applicant is Osteonics Corp.. The 510(k) number is K984585.

When did OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE receive FDA 510(k) clearance?

OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE received FDA 510(k) clearance on 1999-02-24, under 510(k) number K984585.

Who is the listed applicant for OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE?

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 OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE?

The FDA product code for OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE 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 SYSTEMK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSK990158OSTEONICS COMBINATION SCREW RING/BLOCKER

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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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