The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Surgeon Id Mandible Recon Plate.
| Device ID | K190696 |
| 510k Number | K190696 |
| Device Name: | Stryker Surgeon ID Mandible Recon Plate |
| Classification | Plate, Bone |
| Applicant | Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Contact | Zainab Amini |
| Correspondent | Zainab Amini Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327459456 | K190696 | 000 |
| 07613327459029 | K190696 | 000 |
| 07613327459036 | K190696 | 000 |
| 07613327459319 | K190696 | 000 |
| 07613327459326 | K190696 | 000 |
| 07613327459333 | K190696 | 000 |
| 07613327459340 | K190696 | 000 |
| 07613327459357 | K190696 | 000 |
| 07613327459364 | K190696 | 000 |
| 07613327459371 | K190696 | 000 |
| 07613327459388 | K190696 | 000 |
| 07613327459395 | K190696 | 000 |
| 07613327459401 | K190696 | 000 |
| 07613327459418 | K190696 | 000 |
| 07613327459425 | K190696 | 000 |
| 07613327459432 | K190696 | 000 |
| 07613327459449 | K190696 | 000 |
| 07613327459012 | K190696 | 000 |