Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid

Shoulder Prosthesis, Reverse Configuration

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid.

Pre-market Notification Details

• Device ID: K172767
• 510k Number: K172767
• Device Name: Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Zimmer, Inc. 345 East Main Street Warsaw, IN 46580
• Contact: Ehab Esmail
• Correspondent: Andrew Steward; Zimmer, Inc. 56 East Bell Drive Warsaw, IN 46581
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-13
• Decision Date: 2017-11-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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