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

Amendia, Inc. has 16 FDA 510(k) cleared orthopedic devices. Based in Apple Valley, US.

Historical record: 16 cleared submissions from 2009 to 2016.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Amendia, Inc.
16 devices
1-16 of 16
Cleared Nov 08, 2016
Amendia Interbody Fusion Devices
K160924 · MAX
Orthopedic · 218d
Cleared Oct 13, 2016
Overwatch Spine System
K161842 · NKB
Orthopedic · 100d
Cleared Jul 08, 2016
Savannah-T® Pedicle Screw System
K152920 · NKB
Orthopedic · 280d
Cleared Apr 27, 2016
Syzygy Stabilization System
K153152 · NKB
Orthopedic · 177d
Cleared Feb 18, 2016
Optimus ALIF System
K160291 · OVD
Orthopedic · 15d
Cleared Jan 14, 2016
Amendia Stand-Alone Cervical System
K152972 · OVE
Orthopedic · 98d
Cleared Jan 06, 2016
Amendia Interbody Fusion Devices
K151310 · MAX
Orthopedic · 233d
Cleared Dec 22, 2015
Rectangular Corpectomy Cage
K152460 · MQP
Orthopedic · 116d
Cleared Oct 15, 2015
Amendia Cervical Plate System
K152455 · KWQ
Orthopedic · 48d
Cleared Sep 10, 2015
Amendia Interbody Fusion Devices
K151322 · MAX
Orthopedic · 115d
Cleared Aug 10, 2015
Omega LIF System
K150395 · MAX
Orthopedic · 173d
Cleared Mar 06, 2014
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
K133036 · MBI
Orthopedic · 161d
Cleared Feb 11, 2014
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP,...
K132925 · NKB
Orthopedic · 146d
Cleared Dec 06, 2011
SPARTAN S3 FACET SYSTEM
K113011 · MRW
Orthopedic · 56d
Cleared May 13, 2010
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
K100265 · KWQ
Orthopedic · 104d
Cleared Nov 17, 2009
SPARTAN S3 FACET SYSTEM
K092568 · MRW
Orthopedic · 89d
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