Medical Device Manufacturer · US , Apple Valley , MN

Amendia, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2009

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amendia, Inc. Orthopedic ✕

16 devices

1-12 of 16

Cleared Nov 08, 2016

Amendia Interbody Fusion Devices

Orthopedic · 218d

Cleared Oct 13, 2016

Overwatch Spine System

Orthopedic · 100d

Cleared Jul 08, 2016

Savannah-T® Pedicle Screw System

Orthopedic · 280d

Cleared Apr 27, 2016

Syzygy Stabilization System

Orthopedic · 177d

Cleared Feb 18, 2016

Optimus ALIF System

Orthopedic · 15d

Cleared Jan 14, 2016

Amendia Stand-Alone Cervical System

Orthopedic · 98d

Cleared Jan 06, 2016

Amendia Interbody Fusion Devices

Orthopedic · 233d

Cleared Dec 22, 2015

Rectangular Corpectomy Cage

Orthopedic · 116d

Cleared Oct 15, 2015

Amendia Cervical Plate System

Orthopedic · 48d

Cleared Sep 10, 2015

Amendia Interbody Fusion Devices

Orthopedic · 115d

Cleared Aug 10, 2015

Omega LIF System

Orthopedic · 173d

Cleared Mar 06, 2014

APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS

Orthopedic · 161d