The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Locking Screw Mandibular Reconstruction Plate.
| Device ID | K000594 |
| 510k Number | K000594 |
| Device Name: | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE |
| Classification | Plate, Bone |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Robin L Rowe |
| Correspondent | Robin L Rowe STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-12-08 |