Cleared Traditional

Sniper (R) Spine System

K160003 · Spine Wave, Inc. · Orthopedic
Feb 2016
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K160003 is an FDA 510(k) clearance for the Sniper (R) Spine System, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on February 26, 2016, 53 days after receiving the submission on January 4, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K160003 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2016
Decision Date February 26, 2016
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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