K163610 is an FDA 510(k) clearance for the PIEZOTOME M+, PIEZOTOME M+ Handpiece. This device is classified as a Instrument, Surgical, Sonic And Accessory/attachment (Class II - Special Controls, product code JDX).
Submitted by Satalec-Acteon Group (Merignac, FR). The FDA issued a Cleared decision on May 19, 2017, 148 days after receiving the submission on December 22, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K163610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2016 |
| Decision Date | May 19, 2017 |
| Days to Decision | 148 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 |