K163308 is an FDA 510(k) clearance for the SMARTO. This device is classified as a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I - General Controls, product code KIJ).
Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on December 27, 2016, 34 days after receiving the submission on November 23, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K163308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2016 |
| Decision Date | December 27, 2016 |
| Days to Decision | 34 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KIJ — Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |