Cleared Traditional

ANKLE-FOOT CAST/SPLINT

K811690 · Surgical Appliance Industries, Inc. · Physical Medicine
Jun 1981
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K811690 is an FDA 510(k) clearance for the ANKLE-FOOT CAST/SPLINT, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1981, 10 days after receiving the submission on June 15, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K811690 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1981
Decision Date June 25, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IQI — Orthosis, Limb Brace
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475