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FDA 510(k)

PROXIMAL HUMERAL REPLACEMENT SYSTEM

K-Number: K925613 · 1994-10-14

ApplicantBiomet, Inc.
Decision Date1994-10-14
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROXIMAL HUMERAL REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-10-14 under 510(k) number K925613. 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 PROXIMAL HUMERAL REPLACEMENT SYSTEM?

PROXIMAL HUMERAL REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is Biomet, Inc.. The 510(k) number is K925613.

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

PROXIMAL HUMERAL REPLACEMENT SYSTEM received FDA 510(k) clearance on 1994-10-14, under 510(k) number K925613.

Who is the listed applicant for PROXIMAL HUMERAL REPLACEMENT SYSTEM?

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

What is the FDA product code for PROXIMAL HUMERAL REPLACEMENT SYSTEM?

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

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Other records listing Biomet, 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.

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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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