Cleared Traditional

TRYPTIK2C-plate Anterior Cervical Plate System

K153042 · Spineart · Orthopedic
Mar 2016
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K153042 is an FDA 510(k) clearance for the TRYPTIK2C-plate Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on March 28, 2016, 161 days after receiving the submission on October 19, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K153042 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2015
Decision Date March 28, 2016
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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