K063606 is an FDA 510(k) clearance for the MODIFICATION TO STAXX FX SYSTEM. This device is classified as a Cement, Bone, Pre-formed, Modular, Polymeric, Vertebroplasty (Class II - Special Controls, product code OBL).
Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on April 13, 2007, 133 days after receiving the submission on December 1, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027. Reduction Of Vertebral Body Fractures In Conjunction With Pmma Bone Cement Cleared For Vertebroplasty And Restoration Of Vertebral Body Height..
| 510(k) Number | K063606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2006 |
| Decision Date | April 13, 2007 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OBL — Cement, Bone, Pre-formed, Modular, Polymeric, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |
| Definition | Reduction Of Vertebral Body Fractures In Conjunction With Pmma Bone Cement Cleared For Vertebroplasty And Restoration Of Vertebral Body Height. |