The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Staxx(r) Xd System.
| Device ID | K102682 |
| 510k Number | K102682 |
| 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 | Roaiada Rizkallah |
| Correspondent | Roaiada 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-17 |
| Decision Date | 2010-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642100693 | K102682 | 000 |
| 10840642100686 | K102682 | 000 |