Cleared Traditional

Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System

K210016 · Integra LifeSciences Corporation · Orthopedic

Jul 2021

Decision

204d

Days

Class 2

Risk

About This 510(k) Submission

K210016 is an FDA 510(k) clearance for the Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Integra LifeSciences Corporation (Austin, US). The FDA issued a Cleared decision on July 27, 2021, 204 days after receiving the submission on January 4, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K210016 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 2021
Decision Date	July 27, 2021
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF