Cleared Traditional

Streamline OCT Occipito-Cervico-Thoracic System

K150254 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic
Apr 2015
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K150254 is an FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on April 28, 2015, 84 days after receiving the submission on February 3, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K150254 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2015
Decision Date April 28, 2015
Days to Decision 84 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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