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FDA 510(k)

ACCLAIM TOTAL ELBOW SYSTEM

K-Number: K060696 · 2006-04-14

ApplicantDePuy Orthopaedics, Inc.
Decision Date2006-04-14
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCLAIM 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 2006-04-14 under 510(k) number K060696. 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 ACCLAIM TOTAL ELBOW SYSTEM?

ACCLAIM TOTAL ELBOW SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-14. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K060696.

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

ACCLAIM TOTAL ELBOW SYSTEM received FDA 510(k) clearance on 2006-04-14, under 510(k) number K060696.

Who is the listed applicant for ACCLAIM 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 ACCLAIM TOTAL ELBOW SYSTEM?

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

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Other records listing DePuy Orthopaedics, Inc. as applicant

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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 CorpK053189COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIESZimmer, 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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