The following data is part of a premarket notification filed by Biomet Spine with the FDA for Solitaire-c Cervical Spacer System, C-thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System.
| Device ID | K151064 |
| 510k Number | K151064 |
| Device Name: | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | BIOMET SPINE 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Contact | Alexandra Beck |
| Correspondent | Alexandra Beck BIOMET SPINE 310 INTERLOCKEN PARKWAY, SUITE 120 Broomfield, CO 80021 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-08-12 |
| Summary: | summary |