K151227 is an FDA 510(k) clearance for the KYPHON XPEDE Bone Cement. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on November 16, 2015, 193 days after receiving the submission on May 7, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K151227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2015 |
| Decision Date | November 16, 2015 |
| Days to Decision | 193 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 |