Cleared Traditional

K180729 - FaSet Fixation System (FDA 510(k) Clearance)

K180729 · Huvexel Co. , Ltd. · Orthopedic device

Jun 2018

Decision

100d

Days

Risk

K180729 is an FDA 510(k) clearance for the FaSet Fixation System. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Huvexel Co. , Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on June 28, 2018, 100 days after receiving the submission on March 20, 2018.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K180729 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 20, 2018
Decision Date	June 28, 2018
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF