The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Abacus Tm Spacer System.
| Device ID | K140007 |
| 510k Number | K140007 |
| Device Name: | ABACUS TM SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Contact | Joseph Mercado |
| Correspondent | Joseph Mercado SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-02 |
| Decision Date | 2014-04-07 |
| Summary: | summary |