Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate

Shoulder Prosthesis, Reverse Configuration

Biomet Manufacturing Corp

The following data is part of a premarket notification filed by Biomet Manufacturing Corp with the FDA for Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate.

Pre-market Notification Details

• Device ID: K172502
• 510k Number: K172502
• Device Name: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Biomet Manufacturing Corp 56 E. Bell Drive Warsaw, IN 46582
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; Biomet Manufacturing Corp 56 E. Bell Drive Warsaw, IN 46582
• Product Code: PHX
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• Subsequent Product Code: MBF
• Subsequent Product Code: PAO
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-18
• Decision Date: 2018-01-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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