The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Staxx Xd System.
| Device ID | K101288 |
| 510k Number | K101288 |
| Device Name: | STAXX XD SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Contact | Roaida Rizkallah |
| Correspondent | Roaida Rizkallah 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 | 2010-05-07 |
| Decision Date | 2010-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642100754 | K101288 | 000 |
| 10840642100747 | K101288 | 000 |
| 10840642100679 | K101288 | 000 |
| 10840642100662 | K101288 | 000 |
| 10840642100655 | K101288 | 000 |