K122175 is an FDA 510(k) clearance for the MENDEC SPINE HV, MENDEC SPINE HV SYSTEM. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on March 28, 2013, 248 days after receiving the submission on July 23, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K122175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2012 |
| Decision Date | March 28, 2013 |
| Days to Decision | 248 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 |