Cleared Traditional

Mikron Spinal Fixation System

K171497 · Mikron Makina Sanayi Ticaret Co. , Ltd. · Orthopedic

Oct 2017

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K171497 is an FDA 510(k) clearance for the Mikron Spinal Fixation System, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Mikron Makina Sanayi Ticaret Co. , Ltd. (Ankara, TR). The FDA issued a Cleared decision on October 12, 2017, 143 days after receiving the submission on May 22, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K171497 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2017
Decision Date	October 12, 2017
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF