The following data is part of a premarket notification filed by Stryker Craniomaxillofacial with the FDA for The Leibinger Advance Internal Midface Distraction System.
| Device ID | K092743 |
| 510k Number | K092743 |
| Device Name: | THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM |
| Classification | Plate, Bone |
| Applicant | STRYKER CRANIOMAXILLOFACIAL 750 TRADE CENTRE WAY SUITE 200 Kalamazoo, MI 49001 |
| Contact | Robert Yamashita |
| Correspondent | Robert Yamashita STRYKER CRANIOMAXILLOFACIAL 750 TRADE CENTRE WAY SUITE 200 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 | 2009-09-08 |
| Decision Date | 2010-01-15 |
| Summary: | summary |