SMR REVERSE SHOULDER 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 Reverse Shoulder System.

Pre-market Notification Details

• Device ID: K110598
• 510k Number: K110598
• Device Name: SMR REVERSE SHOULDER SYSTEM
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696
• Contact: Cheryl Hastings
• Correspondent: Cheryl Hastings; LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-02
• Decision Date: 2011-08-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390122320	K110598	000
08033390113793	K110598	000
08033390039048	K110598	000
08033390039055	K110598	000
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08033390065221	K110598	000
08033390065238	K110598	000
08033390098908	K110598	000
08033390113786	K110598	000
08033390111546	K110598	000
08033390023498	K110598	000
08033390023511	K110598	000
08033390038980	K110598	000
08033390091701	K110598	000
08033390098373	K110598	000
08033390098380	K110598	000
08033390098403	K110598	000
08033390099042	K110598	000
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08033390046909	K110598	000
08033390128568	K110598	000
08033390164368	K110598	000
08033390023528	K110598	000
08033390098892	K110598	000
08033390099035	K110598	000
08033390120784	K110598	000
08033390122313	K110598	000
08033390071772	K110598	000
08033390071765	K110598	000
08033390132664	K110598	000
08033390091657	K110598	000
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08033390091671	K110598	000
08033390023436	K110598	000
08033390098250	K110598	000
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08033390194617	K110598	000