The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Staxx(r) Xd System.
| Device ID | K111418 |
| 510k Number | K111418 |
| Device Name: | STAXX(R) XD SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SPINE WAVE, INC. 3 ENTERPRISE DR SUITE 210 Shelton, CT 06484 |
| Contact | Roaida Rizkallah |
| Correspondent | Roaida Rizkallah SPINE WAVE, INC. 3 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 | 2011-05-20 |
| Decision Date | 2011-12-13 |
| Summary: | summary |