The following data is part of a premarket notification filed by Synthes Spine with the FDA for Oracle Spacer, Opal Spacer.
| Device ID | K072791 |
| 510k Number | K072791 |
| Device Name: | ORACLE SPACER, OPAL SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-01 |
| Decision Date | 2007-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981SD088032340 | K072791 | 000 |
| H981SD088032160 | K072791 | 000 |
| H981SD088032140 | K072791 | 000 |
| H981SD088031340 | K072791 | 000 |
| H981SD088031160 | K072791 | 000 |
| H981SD088031140 | K072791 | 000 |
| H981SD088030540 | K072791 | 000 |