510(k) DEN200010
DEN200010 is an FDA 510(k) premarket notification submitted by Spineology, Inc. for the device "Spineology Interbody Fusion System". The FDA issued a decision of De Novo Granted on September 18, 2020. The device falls under product code OQB (Intervertebral Body Graft Containment Device), a Class II device regulated under 21 CFR 888.3085. Spineology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 18, 2020
- Date Received
- February 19, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Body Graft Containment Device
- Device Class
- Class II
- Regulation Number
- 888.3085
- Review Panel
- OR
- Submission Type
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.