SMR TT Augmented Glenoid System

Shoulder Prosthesis, Reverse Configuration

Limacorporate S.p.A

The following data is part of a premarket notification filed by Limacorporate S.p.a with the FDA for Smr Tt Augmented Glenoid System.

Pre-market Notification Details

• Device ID: K191746
• 510k Number: K191746
• Device Name: SMR TT Augmented Glenoid System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Limacorporate S.p.A via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038
• Contact: Michela Zanotto
• Correspondent: Stephen Peoples; Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814
• Product Code: PHX
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• Subsequent Product Code: MBF
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-01
• Decision Date: 2019-11-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390167222	K191746	000
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