The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for A-cift Solofuse.
| Device ID | K172484 |
| 510k Number | K172484 |
| Device Name: | A-CIFT SoloFuse |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SpineFrontier, Inc. 350 Main Street 3rd Floor Malden, MA 02148 |
| Contact | Vito Lore |
| Correspondent | Meredith L. May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-17 |
| Decision Date | 2018-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190361023722 | K172484 | 000 |
| 00190361023715 | K172484 | 000 |
| 00190361023708 | K172484 | 000 |
| 00190361023692 | K172484 | 000 |
| 00190361023685 | K172484 | 000 |
| 00190361023678 | K172484 | 000 |
| 00190361023661 | K172484 | 000 |
| 00190361023654 | K172484 | 000 |