The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Duo Expandable Interbody Fusion System.
| Device ID | K210155 |
| 510k Number | K210155 |
| Device Name: | Duo Expandable Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spineology Inc. 7800 3rd Street North Suite 600 Saint Paul, MN 55128 |
| Contact | Andrew Adams |
| Correspondent | Andrew Adams Spineology Inc. 7800 3rd Street North Suite 600 Saint Paul, MN 55128 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2021-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7402954508 | K210155 | 000 |
| M7402956016 | K210155 | 000 |
| M7402964510 | K210155 | 000 |
| M7402964512 | K210155 | 000 |
| M7402964514 | K210155 | 000 |
| M7402964516 | K210155 | 000 |
| M7402965010 | K210155 | 000 |
| M7402965012 | K210155 | 000 |
| M7402965014 | K210155 | 000 |
| M7402965016 | K210155 | 000 |
| M7402965510 | K210155 | 000 |
| M7402965512 | K210155 | 000 |
| M7402965514 | K210155 | 000 |
| M7402965516 | K210155 | 000 |
| M7402966010 | K210155 | 000 |
| M7402966012 | K210155 | 000 |
| M7402966014 | K210155 | 000 |
| M7402956014 | K210155 | 000 |
| M7402956012 | K210155 | 000 |
| M7402954510 | K210155 | 000 |
| M7402954512 | K210155 | 000 |
| M7402954514 | K210155 | 000 |
| M7402954516 | K210155 | 000 |
| M7402955008 | K210155 | 000 |
| M7402955010 | K210155 | 000 |
| M7402955012 | K210155 | 000 |
| M7402955014 | K210155 | 000 |
| M7402955016 | K210155 | 000 |
| M7402955508 | K210155 | 000 |
| M7402955510 | K210155 | 000 |
| M7402955512 | K210155 | 000 |
| M7402955514 | K210155 | 000 |
| M7402955516 | K210155 | 000 |
| M7402956008 | K210155 | 000 |
| M7402956010 | K210155 | 000 |
| M7402966016 | K210155 | 000 |
| M7402974512 | K210155 | 000 |
| M7408610032 | K210155 | 000 |
| M7408610033 | K210155 | 000 |
| M7408610034 | K210155 | 000 |
| M7408610035 | K210155 | 000 |
| M7408610036 | K210155 | 000 |
| M7408610037 | K210155 | 000 |
| M7408610038 | K210155 | 000 |
| M7408610039 | K210155 | 000 |
| M7408610040 | K210155 | 000 |
| M7408610041 | K210155 | 000 |
| M7408610042 | K210155 | 000 |
| M7408610043 | K210155 | 000 |
| M7408610044 | K210155 | 000 |
| M7408610045 | K210155 | 000 |
| M7408610046 | K210155 | 000 |
| M7408610047 | K210155 | 000 |
| M7408610031 | K210155 | 000 |
| M7408610030 | K210155 | 000 |
| M7402974514 | K210155 | 000 |
| M7402974516 | K210155 | 000 |
| M7402975012 | K210155 | 000 |
| M7402975014 | K210155 | 000 |
| M7402975016 | K210155 | 000 |
| M7402975512 | K210155 | 000 |
| M7402975514 | K210155 | 000 |
| M7402975516 | K210155 | 000 |
| M7402976012 | K210155 | 000 |
| M7402976014 | K210155 | 000 |
| M7402976016 | K210155 | 000 |
| M7408610025 | K210155 | 000 |
| M7408610026 | K210155 | 000 |
| M7408610027 | K210155 | 000 |
| M7408610028 | K210155 | 000 |
| M7408610029 | K210155 | 000 |
| M7408610048 | K210155 | 000 |