Turnkey Intergration USA, Inc.
Indianapolis, IN, US
Turnkey Intergration USA, Inc. appears in FDA device records in Indianapolis, IN. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Turnkey Intergration USA, Inc. between 1990 and 1999. The busiest year on record is 1991, with 7. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 3 |
| 1991 | 7 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 6 |
| 1997 | 3 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991405 | OMNI-FIX, HUMERAL NAIL | KTW | Substantially Equivalent | |
| K990523 | B2C, ESPACE REVISION CUP SYSTEM | LPH | Substantially Equivalent | |
| K990307 | OMNI-FIX, NAIL SYSTEM | KTW | Substantially Equivalent | |
| K972411 | LINK CEMENT PLUG | LZN | Substantially Equivalent | |
| K970284 | ARTOS, DIPLOS SYSTEM | KWY | Substantially Equivalent | |
| K970084 | LINK CERCLAGE WIRE SYSTEM | JDQ | Substantially Equivalent | |
| K953653 | LUBINUS SP II HIP SYSTEM | JDG | Substantially Equivalent | |
| K943986 | LINK ENDO MODEL REVISION CUP | HRS | Substantially Equivalent | |
| K951355 | LINK SADDLE PROTHESIS | KWL | Substantially Equivalent | |
| K950397 | SYSTEM 22 VALVE | BYE | Substantially Equivalent | |
| K940297 | UNIVERSAL WRIST | JWI | Substantially Equivalent for Some Indications | |
| K943277 | LINK SADDLE PROTHESIS | Substantially Equivalent | ||
| K931960 | NUFFIELD TOTAL KNEE | JWH | Substantially Equivalent for Some Indications | |
| K923911 | INTRINSIC STEM | LWJ | Substantially Equivalent | |
| K923898 | C-FIT CEMENTED HIP STEM | JDI | Substantially Equivalent | |
| K913708 | VENUS HIP | LWJ | Substantially Equivalent | |
| K912985 | LIMA 28MM CERAMIC HEAD, MODIFICATION | LZO | Substantially Equivalent | |
| K913282 | LIMA RPS SHOULDER | HSD | Substantially Equivalent | |
| K912936 | MAY HUMERUS PLATES | HRS | Substantially Equivalent | |
| K911338 | LIMA CEMENT RESTRICTOR | JDK | Substantially Equivalent | |
| K910547 | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) | LZO | Substantially Equivalent | |
| K910548 | FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) | LZO | Substantially Equivalent | |
| K910010 | Q SYSTEM 28 HIP STEM | LWJ | Substantially Equivalent | |
| K903957 | VSP HIP STEM | JDI | Substantially Equivalent for Some Indications | |
| K902111 | MODIFIED FREEMAN REVISION ACETABULAR CUP | KWA | Substantially Equivalent | |
| K902110 | MODIFIED FREEMAN ACETABULAR CUP | KWA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- LZNCement Obturator
- JDQCerclage, Fixation
- HRSPlate, Fixation, Bone
- JDKProsthesis, Hip, Cement Restrictor
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain