The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Stryker Cmf Medpor Priority Customized Implant Kit.
| Device ID | K191916 |
| 510k Number | K191916 |
| Device Name: | Stryker CMF MEDPOR Priority Customized Implant Kit |
| Classification | Prosthesis, Chin, Internal |
| Applicant | Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Contact | Gregory Gohl |
| Correspondent | Gregory Gohl Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-17 |
| Decision Date | 2019-08-15 |