510(k) K120352 ยท GWO Plate, Cranioplasty, Preformed, Alterable
STRYKER QUIKFLAP STERILE PROCEDURE PACK
| Applicant | Stryker, Porage MI, US |
| Decision | Substantially Equivalent, Jun 11, 2012 |
| Received | Feb 6, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120352
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S
The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid f Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S
The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fi Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium. Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2-
HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium Terminated |
GWO | None listed |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium Terminated |
GWO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.