510(k) K051614

PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS by Lifecore Biomedical, Inc. — Product Code DZE

K051614 is an FDA 510(k) premarket notification submitted by Lifecore Biomedical, Inc. for the device "PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS". The FDA issued a decision of Substantially Equivalent on September 9, 2005. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Lifecore Biomedical, Inc. has at least 10 other 510(k) clearances on record.