CORIN OPTIMOM MODULAR HEAD

Prosthesis, Hip, Hemi-, Femoral, Metal

CORIN U.S.A.

The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Corin Optimom Modular Head.

Pre-market Notification Details

• Device ID: K111911
• 510k Number: K111911
• Device Name: CORIN OPTIMOM MODULAR HEAD
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal
• Applicant: CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Contact: Lucinda Gerber
• Correspondent: Lucinda Gerber; CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Product Code: KWL
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-05
• Decision Date: 2011-08-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055196902756	K111911	000
05055196905825	K111911	000
05055196905832	K111911	000
05055196905849	K111911	000
05055196906082	K111911	000
05055196906099	K111911	000
05055196906105	K111911	000
05055196906112	K111911	000
05055196906129	K111911	000
05055196906136	K111911	000
05055196906143	K111911	000
05055196905818	K111911	000
05055196905801	K111911	000
05055196905535	K111911	000
05055196905542	K111911	000
05055196905559	K111911	000
05055196905566	K111911	000
05055196905573	K111911	000
05055196905757	K111911	000
05055196905764	K111911	000
05055196905771	K111911	000
05055196905788	K111911	000
05055196905795	K111911	000
05055196906150	K111911	000
05055196906167	K111911	000
05055196906174	K111911	000
05055196906846	K111911	000
05055196906853	K111911	000
05055196906860	K111911	000
05055196972810	K111911	000
05055196972827	K111911	000
05055196972841	K111911	000
05055196972858	K111911	000
05055196972872	K111911	000
05055196972889	K111911	000
05055196972902	K111911	000
05055196906839	K111911	000
05055196906822	K111911	000
05055196906181	K111911	000
05055196906198	K111911	000
05055196906273	K111911	000
05055196906280	K111911	000
05055196906303	K111911	000
05055196906310	K111911	000
05055196906334	K111911	000
05055196906341	K111911	000
05055196906808	K111911	000
05055196906815	K111911	000
05055196972919	K111911	000