FDA 510(k)

THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX

K-Number: K043061 · 2004-11-23

Decision Date2004-11-23

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K043061. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX?

THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Zimmer Trabecular. The 510(k) number is K043061.

When did THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX receive FDA 510(k) clearance?

THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX received FDA 510(k) clearance on 2004-11-23, under 510(k) number K043061.

Who is the listed applicant for THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX?

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

What is the FDA product code for THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX?

The FDA product code for THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX is KWS.

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Other records listing Zimmer Trabecular as applicant

K061155VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM K061067TRABECULAR METAL ACETABULAR AUGMENTS K053340TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS K052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM K051756MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

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Related Devices (Code: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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.