BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Bigliani / Flatow (r) The Complete Shoulder Solution.

Pre-market Notification Details

• Device ID: K110791
• 510k Number: K110791
• Device Name: BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
• Classification: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Anthony Francalancia
• Correspondent: Anthony Francalancia; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: KWT
• CFR Regulation Number: 888.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-21
• Decision Date: 2011-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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