Company ยท US
Turnkey Intergration USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1999. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 |
| HRS | Plate, Fixation, Bone | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 |
| JDQ | Cerclage, Fixation | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| JWI | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
| LZN | Cement Obturator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 1999 | K991405 | OMNI-FIX, HUMERAL NAIL Turnkey Intergration USA, Inc. | KTW |
| Apr 30, 1999 | K990523 | B2C, ESPACE REVISION CUP SYSTEM Turnkey Intergration USA, Inc. | LPH |
| Apr 1, 1999 | K990307 | OMNI-FIX, NAIL SYSTEM Turnkey Intergration USA, Inc. | KTW |
| Aug 29, 1997 | K972411 | LINK CEMENT PLUG Turnkey Intergration USA, Inc. | LZN |
| Apr 21, 1997 | K970284 | ARTOS, DIPLOS SYSTEM Turnkey Intergration USA, Inc. | KWY |
| Mar 13, 1997 | K970084 | LINK CERCLAGE WIRE SYSTEM Turnkey Intergration USA, Inc. | JDQ |
| Nov 6, 1995 | K953653 | LUBINUS SP II HIP SYSTEM Turnkey Intergration USA, Inc. | JDG |
| Jul 5, 1995 | K943986 | LINK ENDO MODEL REVISION CUP Turnkey Intergration USA, Inc. | HRS |
| May 25, 1995 | K951355 | LINK SADDLE PROTHESIS Turnkey Intergration USA, Inc. | KWL |
| Apr 14, 1995 | K950397 | SYSTEM 22 VALVE Turnkey Intergration USA, Inc. | BYE |
| Feb 6, 1995 | K940297 | UNIVERSAL WRIST Turnkey Intergration USA, Inc. | JWI |
| Jan 26, 1995 | K943277 | LINK SADDLE PROTHESIS Turnkey Intergration USA, Inc. | |
| Oct 7, 1994 | K931960 | NUFFIELD TOTAL KNEE Turnkey Intergration USA, Inc. | JWH |
| Apr 14, 1993 | K923911 | INTRINSIC STEM Turnkey Intergration USA, Inc. | LWJ |
| Nov 4, 1992 | K923898 | C-FIT CEMENTED HIP STEM Turnkey Intergration USA, Inc. | JDI |
| Jan 27, 1992 | K913708 | VENUS HIP Turnkey Intergration USA, Inc. | LWJ |
| Dec 24, 1991 | K912985 | LIMA 28MM CERAMIC HEAD, MODIFICATION Turnkey Intergration USA, Inc. | LZO |
| Oct 21, 1991 | K913282 | LIMA RPS SHOULDER Turnkey Intergration USA, Inc. | HSD |
| Sep 6, 1991 | K912936 | MAY HUMERUS PLATES Turnkey Intergration USA, Inc. | HRS |
| Jun 28, 1991 | K911338 | LIMA CEMENT RESTRICTOR Turnkey Intergration USA, Inc. | JDK |
| Apr 12, 1991 | K910547 | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) Turnkey Intergration USA, Inc. | LZO |
| Apr 9, 1991 | K910548 | FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) Turnkey Intergration USA, Inc. | LZO |
| Mar 12, 1991 | K910010 | Q SYSTEM 28 HIP STEM Turnkey Intergration USA, Inc. | LWJ |
| Nov 26, 1990 | K903957 | VSP HIP STEM Turnkey Intergration USA, Inc. | JDI |
| Aug 22, 1990 | K902111 | MODIFIED FREEMAN REVISION ACETABULAR CUP Turnkey Intergration USA, Inc. | KWA |
| Aug 22, 1990 | K902110 | MODIFIED FREEMAN ACETABULAR CUP Turnkey Intergration USA, Inc. | KWA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||