K2M, Inc

FDA Regulatory Profile

Summary

Total Recalls
39
510(k) Clearances
123
Inspections
10
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1307-2022Class IIYukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilizationJune 13, 2022
Z-0705-2022Class IIEverest MI XT Inner Dilator, Catalog Number 5101-90167January 13, 2022
Z-0706-2022Class IIEverest MI XT Outer Dilator, Catalog Number 5101-90168January 13, 2022
Z-0104-2022Class IIChesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068September 8, 2021
Z-1697-2021Class IICascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are May 7, 2021
Z-1696-2021Class IICascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are May 7, 2021
Z-1695-2021Class IICascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are inMay 7, 2021
Z-1410-2021Class IIChesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to theMarch 16, 2021
Z-0931-2021Class IIYukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal SystemDecember 14, 2020
Z-0542-2021Class IIEverest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the EverNovember 4, 2020
Z-0520-2021Class IIYukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment November 3, 2020
Z-2016-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2028-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2024-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2010-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2018-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2008-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2021-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2029-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020
Z-2014-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1April 13, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K253545Vulcan Spinal SystemFebruary 10, 2026
K252873Q Interbody InstrumentsFebruary 6, 2026
K211320CAPRI Corpectomy Cage SystemFebruary 24, 2022
K202528Cannulated Power Driver AttachmentOctober 26, 2020
K201006K2M Navigation InstrumentsAugust 7, 2020
K193203MOJAVE Expandable Interbody SystemFebruary 18, 2020
K193129Yukon OCT Spinal SystemFebruary 7, 2020
K192911Brainlab Compatible K2M Navigation InstrumentsNovember 14, 2019
K190179SAHARA Stabilization SystemOctober 3, 2019
K190584CAYMAN LP Plate SystemMay 15, 2019
K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMADecember 12, 2018
K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemNovember 28, 2018
K182182YUKON OCT Spinal SystemNovember 15, 2018
K181890Brainlab Compatible K2M Navigation InstrumentsNovember 9, 2018
K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI MiniOctober 5, 2018
K180777K2M Expandable Interbody SystemAugust 3, 2018
K181119Range (Denali and Mesa) Spinal SystemsJune 26, 2018
K181188EVEREST Spinal SystemMay 30, 2018
K180376K2M Patient Specific RodsApril 5, 2018
K172941CASCADIA Interbody SystemFebruary 12, 2018