The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Oracle Spacer.
| Device ID | K062933 |
| 510k Number | K062933 |
| Device Name: | SYNTHES ORACLE SPACER |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2007-01-31 |
| Summary: | summary |