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FDA 510(k)

BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION

K-Number: K110791 · 2011-09-02

ApplicantZimmer, Inc.
Decision Date2011-09-02
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2011-09-02 under 510(k) number K110791. 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 BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION?

BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION is a medical device that received FDA 510(k) clearance on 2011-09-02. The listed applicant is Zimmer, Inc.. The 510(k) number is K110791.

When did BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION receive FDA 510(k) clearance?

BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION received FDA 510(k) clearance on 2011-09-02, under 510(k) number K110791.

Who is the listed applicant for BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION?

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 BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION?

The FDA product code for BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION is KWT.

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Other records listing Zimmer, 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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