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FDA 510(k)

OSTEONICS TOTAL ELBOW SYSTEM

K-Number: K980502 · 1998-05-05

ApplicantOsteonics Corp.
Decision Date1998-05-05
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS TOTAL ELBOW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1998-05-05 under 510(k) number K980502. The device is classified under product code JDC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS TOTAL ELBOW SYSTEM?

OSTEONICS TOTAL ELBOW SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-05. The listed applicant is Osteonics Corp.. The 510(k) number is K980502.

When did OSTEONICS TOTAL ELBOW SYSTEM receive FDA 510(k) clearance?

OSTEONICS TOTAL ELBOW SYSTEM received FDA 510(k) clearance on 1998-05-05, under 510(k) number K980502.

Who is the listed applicant for OSTEONICS TOTAL ELBOW SYSTEM?

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 TOTAL ELBOW SYSTEM?

The FDA product code for OSTEONICS TOTAL ELBOW SYSTEM is JDC.

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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: JDC)

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.

K181362TEMA Elbow SystemLima Corporate S.P.A.K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc.K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing CorpK123862ZIMMER NEXEL TOTAL ELBOWZimmer, Inc.K090473DISCOVERY ELBOW - X-SMALLBiomet Manufacturing CorpK060696ACCLAIM TOTAL ELBOW SYSTEMDePuy Orthopaedics, Inc.

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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