510(k) K964357

NATURAL-HIP SYSTEM COCR STEM by Intermedics Orthopedics — Product Code LZO

K964357 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "NATURAL-HIP SYSTEM COCR STEM". The FDA issued a decision of Substantially Equivalent on January 27, 1997. 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. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.