Cleared Special

INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

K141376 · Nexxt Spine, LLC · Orthopedic

Jun 2014

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K141376 is an FDA 510(k) clearance for the INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Nexxt Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on June 26, 2014, 30 days after receiving the submission on May 27, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K141376 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2014
Decision Date	June 26, 2014
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF