The following data is part of a premarket notification filed by Spectrum Spine, Llc with the FDA for Spectrum Spine Expandable Cages (ssec).
| Device ID | K173518 |
| 510k Number | K173518 |
| Device Name: | Spectrum Spine Expandable Cages (SSEC) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spectrum Spine, LLC 3045 Paces Lake Court Atlanta, GA 30339 |
| Contact | James Robinson |
| Correspondent | James Robinson Spectrum Spine, LLC 4020 Stovall Terrace NE Atlanta, GA 30342 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-14 |
| Decision Date | 2019-03-07 |