510(k) K080070

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES by Grace Medical, Inc. — Product Code ETB

K080070 is an FDA 510(k) premarket notification submitted by Grace Medical, Inc. for the device "K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES". The FDA issued a decision of Substantially Equivalent on April 17, 2008. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Grace Medical, Inc. has at least 10 other 510(k) clearances on record.