510(k) K801436

ORTHOPEDIC LOWER EXTREMITY SUSPENSION by Orthopedic Systems, Inc. — Product Code FYH

K801436 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "ORTHOPEDIC LOWER EXTREMITY SUSPENSION". The FDA issued a decision of Substantially Equivalent on June 26, 1980. The device falls under product code FYH (Splint, Extremity, Noninflatable, External, Sterile), a Class I device regulated under 21 CFR 878.3910. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.