The following data is part of a premarket notification filed by Apollo Spine with the FDA for Eclipse Vertebral Spacer System-cervical.
| Device ID | K120143 |
| 510k Number | K120143 |
| Device Name: | ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | APOLLO SPINE 128 Blye HIll Landing Newbury, NH 03255 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey APOLLO SPINE 128 Blye HIll Landing Newbury, NH 03255 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-02-16 |
| Summary: | summary |