The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Oracle Plate.
| Device ID | K091159 |
| 510k Number | K091159 |
| Device Name: | SYNTHES ORACLE PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Stacey Bonnell SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-21 |
| Decision Date | 2009-07-10 |
| Summary: | summary |