510(k) K912985

LIMA 28MM CERAMIC HEAD, MODIFICATION by Turnkey Intergration USA, Inc. — Product Code LZO

K912985 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "LIMA 28MM CERAMIC HEAD, MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 24, 1991. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.