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FDA 510(k)

COMPREHENSIVE HUMERAL FRACTURE SYSTEM

K-Number: K023063 · 2002-12-13

ApplicantBiomet Orthopedics, Inc.
Decision Date2002-12-13
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE HUMERAL FRACTURE SYSTEM 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 2002-12-13 under 510(k) number K023063. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPREHENSIVE HUMERAL FRACTURE SYSTEM?

COMPREHENSIVE HUMERAL FRACTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-13. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K023063.

When did COMPREHENSIVE HUMERAL FRACTURE SYSTEM receive FDA 510(k) clearance?

COMPREHENSIVE HUMERAL FRACTURE SYSTEM received FDA 510(k) clearance on 2002-12-13, under 510(k) number K023063.

Who is the listed applicant for COMPREHENSIVE HUMERAL FRACTURE SYSTEM?

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 COMPREHENSIVE HUMERAL FRACTURE SYSTEM?

The FDA product code for COMPREHENSIVE HUMERAL FRACTURE SYSTEM is KWT.

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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: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH

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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