510(k) K980461

SPECTRUM DESIGNS CLEFT CHIN IMPLANT by Spectrum Designs, Inc. — Product Code FWP

K980461 is an FDA 510(k) premarket notification submitted by Spectrum Designs, Inc. for the device "SPECTRUM DESIGNS CLEFT CHIN IMPLANT". The FDA issued a decision of Substantially Equivalent on March 4, 1998. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Spectrum Designs, Inc. has at least 10 other 510(k) clearances on record.