Cleared Traditional

SX-One MicroKnife

K192873 · Sonex Health, Inc. · Orthopedic

Dec 2019

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K192873 is an FDA 510(k) clearance for the SX-One MicroKnife, a Orthopedic Manual Surgical Instrument (Class I — General Controls, product code LXH), submitted by Sonex Health, Inc. (Rochester, US). The FDA issued a Cleared decision on December 20, 2019, 73 days after receiving the submission on October 8, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K192873 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 2019
Decision Date	December 20, 2019
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF