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FDA 510(k)

3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM

K-Number: K020045 · 2002-01-30

ApplicantBiomet Orthopedics, Inc.
Decision Date2002-01-30
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3-PIECE PROXIMAL HUMERAL REPLACEMENT 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 2002-01-30 under 510(k) number K020045. 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 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM?

3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K020045.

When did 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM receive FDA 510(k) clearance?

3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM received FDA 510(k) clearance on 2002-01-30, under 510(k) number K020045.

Who is the listed applicant for 3-PIECE PROXIMAL HUMERAL REPLACEMENT 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 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM?

The FDA product code for 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM is KWT.

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Other records listing Biomet Orthopedics, Inc. as applicant

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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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