Cleared Traditional

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

K031576 · Surgitech, Inc. · Physical Medicine

Jul 2003

Decision

72d

Days

Class 1

Risk

About This 510(k) Submission

K031576 is an FDA 510(k) clearance for the SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Surgitech, Inc. (Oceanside, US). The FDA issued a Cleared decision on July 31, 2003, 72 days after receiving the submission on May 20, 2003. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number	K031576 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2003
Decision Date	July 31, 2003
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement