Cleared Special

TSolution One Surgical System Model 210

K170430 · THINK Surgical, Inc. · Orthopedic

Mar 2017

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K170430 is an FDA 510(k) clearance for the TSolution One Surgical System Model 210, 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 March 6, 2017, 21 days after receiving the submission on February 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K170430 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2017
Decision Date	March 06, 2017
Days to Decision	21 days
Submission Type	Special
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.