Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K152076
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority · Stryker · decided 2015-08-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | 78-40030 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129298 |
| (unnamed) | 78-50020 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129281 |
| (unnamed) | 78-80040 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300109 |
| (unnamed) | 78-80020 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300086 |
| (unnamed) | 78-40010 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129236 |
| (unnamed) | 78-70020 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300017 |
| (unnamed) | 78-70010 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300079 |
| (unnamed) | 78-80030 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300123 |
| (unnamed) | 78-70030 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300055 |
| (unnamed) | 78-80010 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300048 |
| (unnamed) | 78-40100 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129243 |
| (unnamed) | 78-40040 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129250 |
| (unnamed) | 78-70040 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327300031 |
| (unnamed) | 78-50030 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129267 |
| (unnamed) | 78-50040 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129274 |
| (unnamed) | 78-50010 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129328 |
| (unnamed) | 78-40020 | Stryker Leibinger GmbH & Co. KG | GWO | 07613327129335 |