Cleared Special

Panta 2 Arthrodesis Nail System

K181639 · Integra LifeSciences Corporation · Orthopedic
Nov 2018
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K181639 is an FDA 510(k) clearance for the Panta 2 Arthrodesis Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Integra LifeSciences Corporation (Austin, US). The FDA issued a Cleared decision on November 2, 2018, 134 days after receiving the submission on June 21, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K181639 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2018
Decision Date November 02, 2018
Days to Decision 134 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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