The following data is part of a premarket notification filed by Apollo Spine, Inc. with the FDA for Eclipse Vertebral Spacer System-lumbar.
| Device ID | K102121 |
| 510k Number | K102121 |
| Device Name: | ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | APOLLO SPINE, INC. 75 MILL STREET Stoughton, MA 02072 |
| Contact | Christine Santagate |
| Correspondent | Christine Santagate APOLLO SPINE, INC. 75 MILL STREET Stoughton, MA 02072 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2011-01-12 |
| Summary: | summary |