Turnkey Intergration USA, Inc.: FDA clearances and approvals
Turnkey Intergration USA, Inc. has 26 FDA 510(k) clearances (first 1990, latest 1999), across 18 product codes in 2 review panels. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 | 2 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
Plus 8 more product codes.
Review panels
- Orthopedic (24)
- Anesthesiology (1)
Most recent Turnkey Intergration USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991405 | OMNI-FIX, HUMERAL NAIL | KTW | 1999-06-29 | 68 |
| K990523 | B2C, ESPACE REVISION CUP SYSTEM | LPH | 1999-04-30 | 70 |
| K990307 | OMNI-FIX, NAIL SYSTEM | KTW | 1999-04-01 | 59 |
| K972411 | LINK CEMENT PLUG | LZN | 1997-08-29 | 64 |
| K970284 | ARTOS, DIPLOS SYSTEM | KWY | 1997-04-21 | 87 |
| K970084 | LINK CERCLAGE WIRE SYSTEM | JDQ | 1997-03-13 | 63 |
| K953653 | LUBINUS SP II HIP SYSTEM | JDG | 1995-11-06 | 95 |
| K943986 | LINK ENDO MODEL REVISION CUP | HRS | 1995-07-05 | 323 |
| K951355 | LINK SADDLE PROTHESIS | KWL | 1995-05-25 | 78 |
| K950397 | SYSTEM 22 VALVE | BYE | 1995-04-14 | 72 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Turnkey Intergration USA, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Turnkey Intergration USA, Inc. have?
Turnkey Intergration USA, Inc. has 26 FDA 510(k) clearances (first 1990, latest 1999), across 18 product codes in 2 review panels.
How long does FDA take to clear Turnkey Intergration USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Turnkey Intergration USA, Inc.'s cleared 510(k)s is 90 days.
What devices does Turnkey Intergration USA, Inc. make?
Its most frequent FDA product codes are 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).
Has Turnkey Intergration USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Turnkey Intergration USA, Inc. Related entities may recall under other names.
Next steps
- See all 26 Turnkey Intergration USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LWJ, Turnkey Intergration USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.