Cleared Traditional

K862874 - THE TOWERED 90/90 UNIT
(FDA 510(k) Clearance)

K862874 · Lossing Orthopedic, Inc. · Neurology
Aug 1986
Decision
8d
Days
Class 1
Risk

K862874 is an FDA 510(k) clearance for the THE TOWERED 90/90 UNIT, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by Lossing Orthopedic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 7, 1986, 8 days after receiving the submission on July 30, 1986. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.

Submission Details

510(k) Number K862874 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1986
Decision Date August 07, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary

Device Classification

Product Code HST — Apparatus, Traction, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.5850

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