K132848 is an FDA 510(k) clearance for the PIEZOSURGERY FLEX. This device is classified as a Instrument, Surgical, Sonic And Accessory/attachment (Class II - Special Controls, product code JDX).
Submitted by Mectron S.P.A. (Rome, IT). The FDA issued a Cleared decision on November 29, 2013, 79 days after receiving the submission on September 11, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K132848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2013 |
| Decision Date | November 29, 2013 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDX - Instrument, Surgical, Sonic And Accessory/attachment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4580 |