THE C-FIT FEMORAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

CORIN U.S.A.

The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for The C-fit Femoral Hip System.

Pre-market Notification Details

• Device ID: K965019
• 510k Number: K965019
• Device Name: THE C-FIT FEMORAL HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Contact: Jack Thomas
• Correspondent: Jack Thomas; CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-16
• Decision Date: 1997-03-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05055196933835	K965019	000
05055196934221	K965019	000
05055196934337	K965019	000
05055196934344	K965019	000
05055196934351	K965019	000
05055196934375	K965019	000
05055196934481	K965019	000
05055196934498	K965019	000
05055196934504	K965019	000
05055196934511	K965019	000
05055196934528	K965019	000
05055196934214	K965019	000
05055196934207	K965019	000
05055196933842	K965019	000
05055196933859	K965019	000
05055196933866	K965019	000
05055196933873	K965019	000
05055196934030	K965019	000
05055196934047	K965019	000
05055196934054	K965019	000
05055196934061	K965019	000
05055196934184	K965019	000
05055196934191	K965019	000
05055196934580	K965019	000
05055196934634	K965019	000
05055196934641	K965019	000
05055196935327	K965019	000
05055196935334	K965019	000
05055196935396	K965019	000
05055196983212	K965019	000
05055196983229	K965019	000
05055196983236	K965019	000
05055196983243	K965019	000
05055196983250	K965019	000
05055196983267	K965019	000
05055196983274	K965019	000
05055196935310	K965019	000
05055196935273	K965019	000
05055196934658	K965019	000
05055196934665	K965019	000
05055196934672	K965019	000
05055196934689	K965019	000
05055196934696	K965019	000
05055196934702	K965019	000
05055196935211	K965019	000
05055196935228	K965019	000
05055196935235	K965019	000
05055196935242	K965019	000
05055196983298	K965019	000