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K2m, Inc.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories9
Latest FDA decision2026-03-17
TypeNumberDevice NameCodeDateActions
510(k) K260546 Q Pedicle InstrumentsOLO2026-03-17 View
510(k) K253545 Vulcan Spinal SystemNKB2026-02-10 View
510(k) K252873 Q Interbody InstrumentsOLO2026-02-06 View
510(k) K211320 CAPRI Corpectomy Cage SystemPLR2022-02-24 View
510(k) K202528 Cannulated Power Driver AttachmentNKB2020-10-26 View
510(k) K201006 K2M Navigation InstrumentsOLO2020-08-07 View
510(k) K193203 MOJAVE Expandable Interbody SystemMAX2020-02-18 View
510(k) K193129 Yukon OCT Spinal SystemNKG2020-02-07 View
510(k) K192911 Brainlab Compatible K2M Navigation InstrumentsOLO2019-11-14 View
510(k) K190179 SAHARA Stabilization SystemOVD2019-10-03 View
510(k) K190584 CAYMAN LP Plate SystemKWQ2019-05-15 View
510(k) K182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate SystemsKWQ2018-12-12 View
510(k) K181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal SystemNKG2018-10-05 View
510(k) K180777 K2M Expandable Interbody SystemMAX2018-08-03 View
510(k) K181119 Range (Denali and Mesa) Spinal SystemsNKB2018-06-26 View
510(k) K181188 EVEREST Spinal SystemNKB2018-05-30 View
510(k) K180376 K2M Patient Specific RodsNKB2018-04-05 View
510(k) K172009 Cascadia Interbody SystemMAX2017-12-14 View
510(k) K171832 Range/Denali/Mesa Spinal SystemNKB2017-09-14 View
510(k) K172104 Ozark(tm) Cervical Plate SystemKWQ2017-08-23 View

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