Cleared Special

TSolution One Cup1 Surgical System

K162195 · THINK Surgical, Inc. · Orthopedic

Sep 2016

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K162195 is an FDA 510(k) clearance for the TSolution One Cup1 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 September 14, 2016, 40 days after receiving the submission on August 5, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K162195 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2016
Decision Date	September 14, 2016
Days to Decision	40 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.