K152557 is an FDA 510(k) clearance for the Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on February 23, 2016, 168 days after receiving the submission on September 8, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K152557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2015 |
| Decision Date | February 23, 2016 |
| Days to Decision | 168 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 |