Cleared Traditional

SOLSTICE OCT System

K143249 · Life Spine, Inc. · Orthopedic
Apr 2015
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K143249 is an FDA 510(k) clearance for the SOLSTICE OCT System, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on April 7, 2015, 146 days after receiving the submission on November 12, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K143249 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2014
Decision Date April 07, 2015
Days to Decision 146 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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