LUBINUS SP II HIP SYSTEM

Prosthesis, Hip, Femoral Component, Cemented, Metal

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Lubinus Sp Ii Hip System.

Pre-market Notification Details

• Device ID: K953653
• 510k Number: K953653
• Device Name: LUBINUS SP II HIP SYSTEM
• Classification: Prosthesis, Hip, Femoral Component, Cemented, Metal
• Applicant: TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290
• Contact: Douglas W Stuart
• Correspondent: Douglas W Stuart; TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290
• Product Code: JDG
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-03
• Decision Date: 1995-11-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04026575133093	K953653	000
04026575193509	K953653	000
04026575193264	K953653	000
04026575193271	K953653	000
04026575193288	K953653	000
04026575253463	K953653	000
04026575993291	K953653	000
04026575993307	K953653	000
04026575993314	K953653	000
04026575993321	K953653	000
04026575993338	K953653	000
04026575993345	K953653	000
04026575027262	K953653	000
04026575027309	K953653	000
04026575028108	K953653	000
04026575028115	K953653	000
04026575193493	K953653	000
04026575193486	K953653	000
04026575193868	K953653	000
04026575193714	K953653	000
04026575193721	K953653	000
04026575193738	K953653	000
04026575193745	K953653	000
04026575193752	K953653	000
04026575193769	K953653	000
04026575193776	K953653	000
04026575193783	K953653	000
04026575193790	K953653	000
04026575193806	K953653	000
04026575193813	K953653	000
04026575193820	K953653	000
04026575193837	K953653	000
04026575193844	K953653	000
04026575193851	K953653	000
04026575028122	K953653	000
04026575028146	K953653	000
04026575028153	K953653	000
04026575365104	K953653	000
04026575365111	K953653	000
04026575365128	K953653	000
04026575365135	K953653	000
04026575365142	K953653	000
04026575365159	K953653	000
04026575365166	K953653	000
04026575365173	K953653	000
04026575365180	K953653	000
04026575365197	K953653	000
04026575365265	K953653	000
04026575365272	K953653	000
04026575404384	K953653	000
04026575404704	K953653	000
04026575404711	K953653	000
04026575365098	K953653	000
04026575365081	K953653	000
04026575365074	K953653	000
04026575028160	K953653	000
04026575028177	K953653	000
04026575028184	K953653	000
04026575028191	K953653	000
04026575028207	K953653	000
04026575028214	K953653	000
04026575028221	K953653	000
04026575207503	K953653	000
04026575207510	K953653	000
04026575280759	K953653	000
04026575280766	K953653	000
04026575364749	K953653	000
04026575364763	K953653	000
04026575365050	K953653	000
04026575365067	K953653	000
04026575404728	K953653	000