The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Axxess Butterfly Anchor.
| Device ID | K052418 |
| 510k Number | K052418 |
| Device Name: | AXXESS BUTTERFLY ANCHOR |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Steve Tamsett |
| Correspondent | Steve Tamsett ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-02 |
| Decision Date | 2005-09-26 |