Cleared Traditional

Streamline Navigated Instruments

K200095 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic

Jun 2020

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K200095 is an FDA 510(k) clearance for the Streamline Navigated Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on June 26, 2020, 162 days after receiving the submission on January 16, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K200095 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2020
Decision Date	June 26, 2020
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.