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FDA 510(k)

OSTEONICS ELBOW PROSTHESIS

K-Number: K861680 · 1986-06-27

ApplicantOsteonics Corp.
Decision Date1986-06-27
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS ELBOW PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1986-06-27 under 510(k) number K861680. 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 ELBOW PROSTHESIS?

OSTEONICS ELBOW PROSTHESIS is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Osteonics Corp.. The 510(k) number is K861680.

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

OSTEONICS ELBOW PROSTHESIS received FDA 510(k) clearance on 1986-06-27, under 510(k) number K861680.

Who is the listed applicant for OSTEONICS ELBOW PROSTHESIS?

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 ELBOW PROSTHESIS?

The FDA product code for OSTEONICS ELBOW PROSTHESIS 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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