The following data is part of a De Novo classification by Spineology, Inc. with the FDA for Spineology Interbody Fusion System.
| DeNovo ID | DEN200010 |
| Device Name: | Spineology Interbody Fusion System |
| Classification | Intervertebral Body Graft Containment Device |
| Applicant | Spineology, Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128 |
| Contact | Andrew Adams |
| Product Code | OQB |
| CFR Regulation Number | 888.3085 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Orthopedic |
| Classification Advisory | Orthopedic |
| Type | Direct |
| Date Received | 2020-02-19 |
| Decision Date | 2020-09-18 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7403120055 | DEN200010 | 000 |
| M7403001008 | DEN200010 | 000 |
| M7403001015 | DEN200010 | 000 |
| M7403002628 | DEN200010 | 000 |
| M7403003032 | DEN200010 | 000 |
| M7403003440 | DEN200010 | 000 |
| M7403120001 | DEN200010 | 000 |
| M7403120003 | DEN200010 | 000 |
| M7403120004 | DEN200010 | 000 |
| M7401011081 | DEN200010 | 000 |