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FDA 510(k)

NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS

K-Number: K844818 · 1985-07-30

ApplicantOsteonics Corp.
Decision Date1985-07-30
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K844818. 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 NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS?

NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Osteonics Corp.. The 510(k) number is K844818.

When did NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS receive FDA 510(k) clearance?

NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS received FDA 510(k) clearance on 1985-07-30, under 510(k) number K844818.

Who is the listed applicant for NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS?

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 NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS?

The FDA product code for NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS 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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