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FDA 510(k)

DISCOVERY ELBOW

K-Number: K013042 · 2001-10-10

ApplicantBiomet Orthopedics, Inc.
Decision Date2001-10-10
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISCOVERY ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2001-10-10 under 510(k) number K013042. 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 DISCOVERY ELBOW?

DISCOVERY ELBOW is a medical device that received FDA 510(k) clearance on 2001-10-10. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K013042.

When did DISCOVERY ELBOW receive FDA 510(k) clearance?

DISCOVERY ELBOW received FDA 510(k) clearance on 2001-10-10, under 510(k) number K013042.

Who is the listed applicant for DISCOVERY ELBOW?

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

What is the FDA product code for DISCOVERY ELBOW?

The FDA product code for DISCOVERY ELBOW is JDC.

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Other records listing Biomet Orthopedics, 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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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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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