Medical Device Manufacturer · US , Leesburg , VA

K2m, Inc.

99 submissions · 96 cleared · Since 2007
99
Total
96
Cleared
0
Denied

K2m, Inc. — FDA 510(k) Submissions

K2m, Inc. has submitted 99 FDA 510(k) premarket notifications since 2007, of which 96 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Appliance, Fixation, Spinal Intervertebral Body, Orthosis, Spinal Pedicle Fixation, Intervertebral Fusion Device With Bone Graft, Lumbar, Appliance, Fixation, Spinal Interlaminal . Use the specialty filter in the sidebar to narrow results.

99 devices
1–25 of 99
Vulcan Spinal System
K253545 · NKB Thoracolumbosacral... · Orthopedic
Feb 2026 88d
Q Interbody Instruments
K252873 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2026 149d
CAPRI Corpectomy Cage System
K211320 · PLR Spinal Vertebral Body... · Orthopedic
Feb 2022 300d
Cannulated Power Driver Attachment
K202528 · NKB Thoracolumbosacral... · Orthopedic
Oct 2020 55d
K2M Navigation Instruments
K201006 · OLO Orthopedic Stereotaxic... · Orthopedic
Aug 2020 112d
MOJAVE Expandable Interbody System
K193203 · MAX Intervertebral Fusion... · Orthopedic
Feb 2020 90d
Yukon OCT Spinal System
K193129 · NKG Posterior Cervical Screw... · Orthopedic
Feb 2020 87d
Brainlab Compatible K2M Navigation Instruments
K192911 · OLO Orthopedic Stereotaxic... · Orthopedic
Nov 2019 30d
SAHARA Stabilization System
K190179 · OVD Intervertebral Fusion... · Orthopedic
Oct 2019 244d
CAYMAN LP Plate System
K190584 · KWQ Appliance, Fixation,... · Orthopedic
May 2019 70d
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
K182473 · KWQ Appliance, Fixation,... · Orthopedic
Dec 2018 93d
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
K181603 · NKG Posterior Cervical Screw... · Orthopedic
Oct 2018 108d
K2M Expandable Interbody System
K180777 · MAX Intervertebral Fusion... · Orthopedic
Aug 2018 130d
Range (Denali and Mesa) Spinal Systems
K181119 · NKB Thoracolumbosacral... · Orthopedic
Jun 2018 60d
EVEREST Spinal System
K181188 · NKB Thoracolumbosacral... · Orthopedic
May 2018 27d
K2M Patient Specific Rods
K180376 · NKB Thoracolumbosacral... · Orthopedic
Apr 2018 52d
Cascadia Interbody System
K172009 · MAX Intervertebral Fusion... · Orthopedic
Dec 2017 164d
Range/Denali/Mesa Spinal System
K171832 · NKB Thoracolumbosacral... · Orthopedic
Sep 2017 86d
Ozark(tm) Cervical Plate System
K172104 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2017 42d
YUKON OCT Spinal System
K171444 · NKG Posterior Cervical Screw... · Orthopedic
Aug 2017 84d
MOJAVE Expandable Interbody System
K171097 · MAX Intervertebral Fusion... · Orthopedic
May 2017 27d
NILE Proximal Fixation Spinal System
K161332 · OWI Bone Fixation Cerclage,... · Orthopedic
Apr 2017 328d
Pyrenees Cervical Plate System
K162664 · KWQ Appliance, Fixation,... · Orthopedic
Oct 2016 11d
Cascadia Interbody System
K162264 · MAX Intervertebral Fusion... · Orthopedic
Sep 2016 41d
K2M Growing Spine System
K161028 · PGM Growing Rod System · Orthopedic
Jul 2016 101d

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