The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Staxx Xdl System.
| Device ID | K102315 |
| 510k Number | K102315 |
| Device Name: | STAXX XDL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-16 |
| Decision Date | 2011-08-19 |
| Summary: | summary |