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FDA 510(k)

ZIMMER TRABECULAR METAL HUMERAL STEM

K-Number: K041549 · 2004-09-01

ApplicantZimmer, Inc.
Decision Date2004-09-01
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIMMER TRABECULAR METAL HUMERAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2004-09-01 under 510(k) number K041549. 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 ZIMMER TRABECULAR METAL HUMERAL STEM?

ZIMMER TRABECULAR METAL HUMERAL STEM is a medical device that received FDA 510(k) clearance on 2004-09-01. The listed applicant is Zimmer, Inc.. The 510(k) number is K041549.

When did ZIMMER TRABECULAR METAL HUMERAL STEM receive FDA 510(k) clearance?

ZIMMER TRABECULAR METAL HUMERAL STEM received FDA 510(k) clearance on 2004-09-01, under 510(k) number K041549.

Who is the listed applicant for ZIMMER TRABECULAR METAL HUMERAL STEM?

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

What is the FDA product code for ZIMMER TRABECULAR METAL HUMERAL STEM?

The FDA product code for ZIMMER TRABECULAR METAL HUMERAL STEM is KWT.

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Other records listing Zimmer, 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.

K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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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