Cleared Special

Latera Absorbable Nasal Implant

K161191 · Spirox, Inc. · Ear, Nose, Throat
Jun 2016
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K161191 is an FDA 510(k) clearance for the Latera Absorbable Nasal Implant, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by Spirox, Inc. (Menlo Park, US). The FDA issued a Cleared decision on June 23, 2016, 57 days after receiving the submission on April 27, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K161191 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2016
Decision Date June 23, 2016
Days to Decision 57 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.