Cleared Traditional

STAX FINGER SPLINTS

K823393 · Orthopedic Systems, Inc. · Physical Medicine
Dec 1982
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K823393 is an FDA 510(k) clearance for the STAX FINGER SPLINTS, a Splint, Hand, And Components (Class I — General Controls, product code ILH), submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982, 21 days after receiving the submission on November 12, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K823393 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1982
Decision Date December 03, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILH — Splint, Hand, And Components
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475