Cleared Traditional

SOLSTICE OCT System

K142253 · Life Spine, Inc. · Orthopedic
Apr 2015
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K142253 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 23, 2015, 252 days after receiving the submission on August 14, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K142253 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2014
Decision Date April 23, 2015
Days to Decision 252 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

Similar Devices — KWP Appliance, Fixation, Spinal Interlaminal

All 429
LnK Posterior Cervical Fixation System
K143278 · L & K Biomed Co., Ltd. · Jul 2015
OASYS System
K150753 · Stryker Corporation · Jun 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · Precision Spine, Inc. · Jun 2015
Reliance Posterior Cervical-Thoracic System
K142867 · Reliance Medical Systems, LLC · Apr 2015
Streamline OCT Occipito-Cervico-Thoracic System
K150254 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Apr 2015
SOLSTICE OCT System
K143249 · Life Spine, Inc. · Apr 2015