Cleared Traditional

LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS

K012409 · Walter Lorenz Surgical, Inc. · Ear, Nose, Throat

Oct 2001

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K012409 is an FDA 510(k) clearance for the LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 18, 2001, 80 days after receiving the submission on July 30, 2001. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K012409 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2001
Decision Date	October 18, 2001
Days to Decision	80 days
Submission Type	Traditional
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.