Cleared Traditional

LUMBO-SACRAL FLEXION ORTHOSIS

K811494 · Surgical Appliance Industries, Inc. · Physical Medicine
Jun 1981
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K811494 is an FDA 510(k) clearance for the LUMBO-SACRAL FLEXION ORTHOSIS, a Orthosis, Lumbo-sacral (Class I — General Controls, product code IPY), submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981, 20 days after receiving the submission on May 27, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3490.

Submission Details

510(k) Number K811494 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1981
Decision Date June 16, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IPY — Orthosis, Lumbo-sacral
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3490