Cleared Traditional

TSolution One w/ACG+ Surgical System

K153647 · THINK Surgical, Inc. · Orthopedic

Feb 2016

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K153647 is an FDA 510(k) clearance for the TSolution One w/ACG+ Surgical System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by THINK Surgical, Inc. (Fremont, US). The FDA issued a Cleared decision on February 16, 2016, 57 days after receiving the submission on December 21, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K153647 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2015
Decision Date	February 16, 2016
Days to Decision	57 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.