Cleared Traditional

FixxSure? X-Link

K162143 · Innovasis, Inc. · Orthopedic
Sep 2016
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K162143 is an FDA 510(k) clearance for the FixxSure? X-Link, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 23, 2016, 53 days after receiving the submission on August 1, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K162143 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2016
Decision Date September 23, 2016
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070