LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,

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

LIMA-LTO S.P.A.

The following data is part of a premarket notification filed by Lima-lto S.p.a. with the FDA for Lima-lto Smr Shoulder System - Finned Humeral Stems, Lima-lto Smr Shoulder System - Finned Humeral Bodies,.

Pre-market Notification Details

• Device ID: K101263
• 510k Number: K101263
• Device Name: LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
• Classification: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
• Applicant: LIMA-LTO S.P.A. PO BOX 696 Winona Lake, IN 46590
• Contact: Cheryl Hastings
• Correspondent: Cheryl Hastings; LIMA-LTO S.P.A. PO BOX 696 Winona Lake, IN 46590
• Product Code: KWT
• CFR Regulation Number: 888.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-05-05
• Decision Date: 2011-01-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390019941	K101263	000
08033390000895	K101263	000
08033390000901	K101263	000
08033390000918	K101263	000
08033390000925	K101263	000
08033390000932	K101263	000
08033390000949	K101263	000
08033390000956	K101263	000
08033390000963	K101263	000
08033390000970	K101263	000
08033390000987	K101263	000
08033390019927	K101263	000
08033390019934	K101263	000
08033390000888	K101263	000