The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for A-cift Solofuse.
| Device ID | K151198 |
| 510k Number | K151198 |
| Device Name: | A-CIFT SoloFuse |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE 3500 Beverly, MA 01915 |
| Contact | Manthan J Damani |
| Correspondent | Kenneth C Maxwell Ii Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-05 |
| Decision Date | 2015-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190361037408 | K151198 | 000 |
| 00190361037392 | K151198 | 000 |
| 00190361037385 | K151198 | 000 |
| 00190361037378 | K151198 | 000 |
| 00190361037361 | K151198 | 000 |
| 00190361037354 | K151198 | 000 |
| 00190361037347 | K151198 | 000 |
| 00190361037330 | K151198 | 000 |
| 00190361037323 | K151198 | 000 |