Cleared Traditional

K831044 - LIMITED MOTION FUNCTIONAL KNEE BRACE
(FDA 510(k) Clearance)

K831044 · Orthopedic Systems, Inc. · Physical Medicine

Jun 1983

Decision

85d

Days

Class 1

Risk

K831044 is an FDA 510(k) clearance for the LIMITED MOTION FUNCTIONAL KNEE BRACE, a Joint, Knee, External Brace (Class I — General Controls, product code ITQ), submitted by Orthopedic Systems, Inc. (Walker, US). The FDA issued a Cleared decision on June 24, 1983, 85 days after receiving the submission on March 31, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number	K831044 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 1983
Decision Date	June 24, 1983
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—