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FDA 510(k)

DEPUY TOTAL ELBOW SYSTEM

K-Number: K992656 · 1999-11-05

ApplicantDePuy Orthopaedics, Inc.
Decision Date1999-11-05
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY TOTAL ELBOW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 1999-11-05 under 510(k) number K992656. 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 DEPUY TOTAL ELBOW SYSTEM?

DEPUY TOTAL ELBOW SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-05. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K992656.

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

DEPUY TOTAL ELBOW SYSTEM received FDA 510(k) clearance on 1999-11-05, under 510(k) number K992656.

Who is the listed applicant for DEPUY TOTAL ELBOW SYSTEM?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing DePuy Orthopaedics, Inc. 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.

K262130ATTUNE Revision Knee SystemK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

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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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