Cleared Traditional

Sapphire X3 Anterior Cervical Plate System

K231593 · Spinal Elements, Inc. · Orthopedic
Aug 2023
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K231593 is an FDA 510(k) clearance for the Sapphire X3 Anterior Cervical Plate 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 August 2, 2023, 62 days after receiving the submission on June 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K231593 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2023
Decision Date August 02, 2023
Days to Decision 62 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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