SMR Shoulder System

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

Limacorporate S.p.A.

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

Pre-market Notification Details

• Device ID: K161476
• 510k Number: K161476
• Device Name: SMR Shoulder System
• Classification: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
• Applicant: Limacorporate S.p.A. Via Nazionale, 52 Villanova Di San Daniele Udine, IT 33038
• Contact: Sara Viel
• Correspondent: Stephen J. Peoples; Limacorporate S.p.A. Via Nazionale, 52 Villanova Di San Daniele Udine, IT 33038
• Product Code: KWT
• CFR Regulation Number: 888.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-27
• Decision Date: 2016-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390273657	K161476	000
08033390273879	K161476	000
08033390273909	K161476	000
08033390273923	K161476	000
08033390273961	K161476	000
08033390273992	K161476	000
08033390274012	K161476	000
08033390274036	K161476	000
08033390274043	K161476	000
08033390274050	K161476	000
08033390274067	K161476	000
08033390273855	K161476	000
08033390273848	K161476	000
08033390273671	K161476	000
08033390273688	K161476	000
08033390273695	K161476	000
08033390273701	K161476	000
08033390273725	K161476	000
08033390273794	K161476	000
08033390273800	K161476	000
08033390273817	K161476	000
08033390273824	K161476	000
08033390273831	K161476	000
08033390274081	K161476	000
08033390274142	K161476	000
08033390274159	K161476	000
08033390274449	K161476	000
08033390274456	K161476	000
08033390274463	K161476	000
08033390274470	K161476	000
08033390274487	K161476	000
08033390274494	K161476	000
08033390274517	K161476	000
08033390274524	K161476	000
08033390274531	K161476	000
08033390274548	K161476	000
08033390274432	K161476	000
08033390274425	K161476	000
08033390274166	K161476	000
08033390274197	K161476	000
08033390274241	K161476	000
08033390274265	K161476	000
08033390274289	K161476	000
08033390274302	K161476	000
08033390274326	K161476	000
08033390274340	K161476	000
08033390274357	K161476	000
08033390274401	K161476	000
08033390274555	K161476	000