510(k) K933101

THE OSTEOMED B POWER SYSTEM AND ACCESSORIES by Osteomed Corp. — Product Code KIJ

K933101 is an FDA 510(k) premarket notification submitted by Osteomed Corp. for the device "THE OSTEOMED B POWER SYSTEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 7, 1994. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Osteomed Corp. has at least 10 other 510(k) clearances on record.