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FDA 510(k)

TOWNLEY TOTAL ELBOW SYSTEM

K-Number: K955916 · 1996-08-08

ApplicantBiologically Oriented Prostheses
Decision Date1996-08-08
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOWNLEY TOTAL ELBOW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biologically Oriented Prostheses. It received FDA 510(k) clearance on 1996-08-08 under 510(k) number K955916. 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 TOWNLEY TOTAL ELBOW SYSTEM?

TOWNLEY TOTAL ELBOW SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Biologically Oriented Prostheses. The 510(k) number is K955916.

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

TOWNLEY TOTAL ELBOW SYSTEM received FDA 510(k) clearance on 1996-08-08, under 510(k) number K955916.

Who is the listed applicant for TOWNLEY TOTAL ELBOW SYSTEM?

The FDA 510(k) record lists Biologically Oriented Prostheses as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOWNLEY TOTAL ELBOW SYSTEM?

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

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Other records listing Biologically Oriented Prostheses 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.

K002325WUJIN #3 TIBIAL NAILK992144BIOPRO RIMMED ACETABULAR COMPOMENTK964472RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTK962769HORIZON HIP SYSTEMK954768BIOPRO HEMI-ENDO MODULAR CERAMIC HEADK952731TOWNLEY ALL POLY ACETABULAR CUP

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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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