The following data is part of a premarket notification filed by Ebi, Llc with the FDA for Solitaire-c Cervical Spacer System.
| Device ID | K113796 |
| 510k Number | K113796 |
| Device Name: | SOLITAIRE-C CERVICAL SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| Contact | Margaret Crowe |
| Correspondent | Margaret Crowe EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-04-26 |
| Summary: | summary |