SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS

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 Modular Glenoid-metal-back Smr Modular Glenoid-liner Smr Modular Glenoid-bone Screws.

Pre-market Notification Details

• Device ID: K113254
• 510k Number: K113254
• Device Name: SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS
• 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: 2011-11-03
• Decision Date: 2012-02-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390080477	K113254	000
08033390080460	K113254	000
08033390080453	K113254	000
08033390080446	K113254	000
08033390002622	K113254	000
08033390002615	K113254	000
08033390002608	K113254	000
08033390002592	K113254	000