510(k) K924654

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT by Sutter Corp. — Product Code BXB

K924654 is an FDA 510(k) premarket notification submitted by Sutter Corp. for the device "FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT". The FDA issued a decision of Substantially Equivalent on February 22, 1993. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Sutter Corp. has at least 6 other 510(k) clearances on record.