DEN200010 is an FDA 510(k) submission for the Spineology Interbody Fusion System. This device is classified as a Intervertebral Body Graft Containment Device (Class II - Special Controls, product code OQB).
Submitted by Spineology, Inc. (Saint Paul, US). The FDA issued a Not Cleared (DENG) decision on September 18, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3085. An Intervertebral Body Graft Containment Device Is A Non-rigid, Implanted Spinal Device That Is Designed To Contain Bone Graft Within Its Internal Cavity. The Device Is Inserted Into The Intervertebral Body Space Of The Spine And Is Intended As An Adjunct To Intervertebral Body Fusion..
| 510(k) Number | DEN200010 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 19, 2020 |
| Decision Date | September 18, 2020 |
| Days to Decision | 212 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | OQB — Intervertebral Body Graft Containment Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3085 |
| Definition | An Intervertebral Body Graft Containment Device Is A Non-rigid, Implanted Spinal Device That Is Designed To Contain Bone Graft Within Its Internal Cavity. The Device Is Inserted Into The Intervertebral Body Space Of The Spine And Is Intended As An Adjunct To Intervertebral Body Fusion. |