The following data is part of a premarket notification filed by Stryker Craniomaxillofacial (cmf) with the FDA for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon Id Mandible Recon Plate.
| Device ID | K222650 |
| 510k Number | K222650 |
| Device Name: | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon ID Mandible Recon Plate |
| Classification | Plate, Bone |
| Applicant | Stryker Craniomaxillofacial (CMF) 1941 Stryker Way Portage, MI 49002 |
| Contact | Zainab Amini |
| Correspondent | Zainab Amini Stryker Craniomaxillofacial (CMF) 1941 Stryker Way Portage, MI 49002 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-01 |
| Decision Date | 2022-12-09 |