Cleared Traditional

Sapphire? Spinal System, Sapphire X Anterior Cervical Plate Spinal System

K201029 · Spinal Elements, Inc. · Orthopedic
Jun 2020
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K201029 is an FDA 510(k) clearance for the Sapphire? Spinal System, Sapphire X Anterior Cervical Plate Spinal System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 17, 2020, 58 days after receiving the submission on April 20, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K201029 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2020
Decision Date June 17, 2020
Days to Decision 58 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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