The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Arena-c Tifuse Cervical Intervertebral Body Fusion Device.
| Device ID | K141333 |
| 510k Number | K141333 |
| Device Name: | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINEFRONTIER, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith May Ms, Rac |
| Correspondent | Meredith May Ms, Rac SPINEFRONTIER, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-11-25 |
| Summary: | summary |