The following data is part of a premarket notification filed by Camber Spine with the FDA for Camber Spine Coveris Cervical Cage.
| Device ID | K133529 |
| 510k Number | K133529 |
| Device Name: | CAMBER SPINE COVERIS CERVICAL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CAMBER SPINE 90 S. NEWTOWN STREET RD. SUITE 10 Newtown Square, PA 19073 |
| Contact | Daniel A Pontecorvo |
| Correspondent | Daniel A Pontecorvo CAMBER SPINE 90 S. NEWTOWN STREET RD. SUITE 10 Newtown Square, PA 19073 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-03-20 |
| Summary: | summary |