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FDA 510(k)

KDR ACETABULAR COMPONENT

K-Number: K895702 · 1989-11-03

ApplicantOsteonics Corp.
Decision Date1989-11-03
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KDR ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K895702. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KDR ACETABULAR COMPONENT?

KDR ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Osteonics Corp.. The 510(k) number is K895702.

When did KDR ACETABULAR COMPONENT receive FDA 510(k) clearance?

KDR ACETABULAR COMPONENT received FDA 510(k) clearance on 1989-11-03, under 510(k) number K895702.

Who is the listed applicant for KDR ACETABULAR COMPONENT?

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 KDR ACETABULAR COMPONENT?

The FDA product code for KDR ACETABULAR COMPONENT is LWJ.

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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: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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