Turnkey Intergration USA, Inc.
Medical device manufacturer in Sarasota, FL.
26510(k) clearances
0PMA approvals
0recalls
Device types
- LWJ Prosthesis, Hip, Semi-Constrained… 3
- LZO Prosthesis, Hip, Semi-Constrained… 3
- JDI Prosthesis, Hip, Semi-Constrained… 2
- KWA Prosthesis, Hip, Semi-Constrained (Metal… 2
- HRS Plate, Fixation, Bone 2
- KTW Appliance, Fixation, Nail/Blade/Plate… 2
- LPH Prosthesis, Hip, Semi-Constrained… 1
- LZN Cement Obturator 1
- KWY Prosthesis, Hip, Hemi-, Femoral… 1
- JDQ Cerclage, Fixation 1
- JDG Prosthesis, Hip, Femoral Component… 1
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal 1
- BYE Attachment, Breathing, Positive End… 1
- JWI Prosthesis, Wrist, 2 Part Metal-Plastic… 1
- JWH Prosthesis, Knee, Patellofemorotibial… 1
- HSD Prosthesis, Shoulder, Hemi-, Humeral… 1
- JDK Prosthesis, Hip, Cement Restrictor 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K991405 | Omni-Fix, Humeral NailKTW · Traditional | 06/29/1999SE |
| K990523 | B2C, Espace Revision Cup SystemLPH · Traditional | 04/30/1999SE |
| K990307 | Omni-Fix, Nail SystemKTW · Traditional | 04/01/1999SE |
| K972411 | Link Cement PlugLZN · Traditional | 08/29/1997SE |
| K970284 | Artos, Diplos SystemKWY · Traditional | 04/21/1997SE |
| K970084 | Link Cerclage Wire SystemJDQ · Traditional | 03/13/1997SE |
| K953653 | Lubinus SP II Hip SystemJDG · Traditional | 11/06/1995SE |
| K943986 | Link Endo Model Revision CupHRS · Traditional | 07/05/1995SE |
| K951355 | Link Saddle ProthesisKWL · Traditional | 05/25/1995SE |
| K950397 | System 22 ValveBYE · Traditional | 04/14/1995SE |
| K940297 | Universal WristJWI · Traditional | 02/06/1995SN |
| K943277 | Link Saddle Prothesis · Traditional | 01/26/1995SE |
| K931960 | Nuffield Total KneeJWH · Traditional | 10/07/1994SN |
| K923911 | Intrinsic StemLWJ · Traditional | 04/14/1993SE |
| K923898 | C-Fit Cemented Hip StemJDI · Traditional | 11/04/1992SE |
| K913708 | Venus HipLWJ · Traditional | 01/27/1992SE |
| K912985 | Lima 28MM Ceramic Head, ModificationLZO · Traditional | 12/24/1991SE |
| K913282 | Lima RPS ShoulderHSD · Traditional | 10/21/1991SE |
| K912936 | May Humerus PlatesHRS · Traditional | 09/06/1991SE |
| K911338 | Lima Cement RestrictorJDK · Traditional | 06/28/1991SE |
| K910547 | Feldmuehle Ceramic Head (12/14 X 28MM)LZO · Traditional | 04/12/1991SE |
| K910548 | Feldmuehle Ceramic Head (12/14 X 32MM)LZO · Traditional | 04/09/1991SE |
| K910010 | Q System 28 Hip StemLWJ · Traditional | 03/12/1991SE |
| K903957 | VSP Hip StemJDI · Traditional | 11/26/1990SN |
| K902111 | Modified Freeman Revision Acetabular CupKWA · Traditional | 08/22/1990SE |
| K902110 | Modified Freeman Acetabular CupKWA · Traditional | 08/22/1990SE |