Mako Surgical Corp.

Mako Surgical Corp. — FDA 510(k) Submissions

Mako Surgical Corp. has submitted 33 FDA 510(k) premarket notifications since 2005, of which 33 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Orthopedic Stereotaxic Instrument, Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer, Neurological Stereotaxic Instrument, Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer, Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer . Use the specialty filter in the sidebar to narrow results.