K053336 is an FDA 510(k) clearance for the STAXX FX SYSTEM. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on July 3, 2006, 214 days after receiving the submission on December 1, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K053336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2005 |
| Decision Date | July 03, 2006 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN — Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |