510(k) K041991

ASPIREX - BONE MARROW ASPIRATE KIT by Isotis Orthobiologics, Inc. — Product Code FMF

K041991 is an FDA 510(k) premarket notification submitted by Isotis Orthobiologics, Inc. for the device "ASPIREX - BONE MARROW ASPIRATE KIT". The FDA issued a decision of Substantially Equivalent on September 16, 2004. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Isotis Orthobiologics, Inc. has at least 9 other 510(k) clearances on record.