Cleared Special

SMARTO

K163308 · Jeil Medical Corporation · Orthopedic

Dec 2016

Decision

34d

Days

Class 1

Risk

About This 510(k) Submission

K163308 is an FDA 510(k) clearance for the SMARTO, 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 review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K163308 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	KIJ — Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820