Cleared Traditional

JACOB WIRZ TRANSFIXATION PIN

K811209 · Colmed, Ltd. · Dental
Jun 1981
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K811209 is an FDA 510(k) clearance for the JACOB WIRZ TRANSFIXATION PIN, a Splint, Endodontic Stabilizing (Class II — Special Controls, product code ELS), submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981, 46 days after receiving the submission on May 1, 1981. This device falls under the Dental review panel. Regulated under 21 CFR 872.3890.

Submission Details

510(k) Number K811209 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1981
Decision Date June 16, 1981
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ELS — Splint, Endodontic Stabilizing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3890