Amplitude Surgical Files for ANATOMIC Knee 510(k)
Amplitude Surgical filed for FDA 510(k) clearance of its posterior stabilized ANATOMIC® knee prosthesis.
This would be the fourth geographic regulatory milestone for the product, which is presently registered in the EU (1Q13), Australia (3Q15) and more recently in South Africa. The device has been used in >17,000 surgeries since launch.
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Sources: Amplitude Surgical; ORTHOWORLD Inc.