510(k) K011554

LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT by Biomet, Inc. — Product Code MIX

K011554 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT". The FDA issued a decision of Substantially Equivalent on June 26, 2001. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Biomet, Inc. has at least 10 other 510(k) clearances on record.