K2m, Inc.
K2m, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2026, with 39 FDA device recalls on record.
Top product codes for K2m, Inc.
FDA recalls by K2m, Inc.
10 most recent of 39- Z-1307-2022 — Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
- Z-0705-2022 — Everest MI XT Inner Dilator, Catalog Number 5101-90167
- Z-0706-2022 — Everest MI XT Outer Dilator, Catalog Number 5101-90168
- Z-0104-2022 — Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
- Z-1697-2021 — Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.
- Z-1696-2021 — Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.
- Z-1695-2021 — Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.
- Z-1410-2021 — Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
- Z-0931-2021 — Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Z-0542-2021 — Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by K2m, Inc.
- K260546 — Q Pedicle Instruments
- K253545 — Vulcan Spinal System
- K252873 — Q Interbody Instruments
- K211320 — CAPRI Corpectomy Cage System
- K202528 — Cannulated Power Driver Attachment
- K201006 — K2M Navigation Instruments
- K193203 — MOJAVE Expandable Interbody System
- K193129 — Yukon OCT Spinal System
- K192911 — Brainlab Compatible K2M Navigation Instruments
- K190179 — SAHARA Stabilization System
- K190584 — CAYMAN LP Plate System
- K182473 — PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
- K181603 — EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
- K180777 — K2M Expandable Interbody System
- K181119 — Range (Denali and Mesa) Spinal Systems
- K181188 — EVEREST Spinal System
- K180376 — K2M Patient Specific Rods
- K172009 — Cascadia Interbody System
- K171832 — Range/Denali/Mesa Spinal System
- K172104 — Ozark(tm) Cervical Plate System
- K171444 — YUKON OCT Spinal System
- K171097 — MOJAVE Expandable Interbody System
- K161332 — NILE Proximal Fixation Spinal System
- K162664 — Pyrenees Cervical Plate System
- K162264 — Cascadia Interbody System
- K161028 — K2M Growing Spine System
- K160208 — NILE Alternative Fixation Spinal System
- K151481 — Sahara Stabilization System
- K151727 — Everest Spinal System
- K152015 — Pyrenees Cervical Plate System
- K150481 — Cascadia Interbody System
- K151216 — Everest Spinal System
- K142487 — Chesapeake Stabilization System
- K142212 — Pyrenees Cervical Plate System
- K150325 — Range/Denali/Mesa Spinal System
- K143350 — Nile Alternative Fixation
- K142360 — Everest Spinal System
- K143334 — Range/Denali/Mesa Spinal System
- K142016 — CAPRI
- K141873 — RANGE/MESA/DENALI SPINAL SYSTEM
- K133402 — K2M MODULAR HOOKS
- K141284 — CASPIAN SPINAL SYSTEM
- K140765 — RANGE/MESA/DENALI SPINAL SYSTEM
- K133288 — CASPIAN OCT SPINAL SYSTEM
- K133494 — CHESAPEAKE SPINAL SYSTEM
- K141147 — RANGE SPINAL SYSTEM
- K133614 — ALEUTIAN IBF SYSTEM
- K133944 — RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
- K132757 — EVEREST SPINAL SYSTEM
- K131533 — CAYMAN MI PLATE SYSTEM
- K132361 — EVEREST SPINAL SYSTEM
- K131784 — RANGE SPINAL SYSTEM
- K130699 — ALEUTIAN SPINAL SYSTEM
- K131030 — RANGE SPINAL SYSTEM
- K122877 — RANGE SPINAL SYSTEM, SMALL STATURE
- K130330 — RANGE SPINAL SYSTEM
- K123412 — RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
- K121630 — RANGE SPINAL SYSTEM
- K121808 — CASIAN, 3.5/4.5 CONNECTORS
- K121016 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K120899 — RANGE SPINAL SYSTEM, UNIT ROD
- K120099 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K120656 — EVEREST SPINAL SYSTEM
- K120031 — CHESAPEAKE SPINAL SYSTEM
- K111294 — SANTORINI SPINAL SYSTEM
- K113329 — K2M, PYRENEES CERVICAL PLATE SYSTEM
- K113654 — CASPIAN
- K113138 — ALEUTIAN SYSTEM
- K112920 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K112037 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K111439 — CHESAPEAKE (CERVICAL COMPONENTS)
- K111135 — PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
- K110991 — MESA SPINAL SYSTEM (KEYSTONE RODS)
- K110843 — ALEUTIAN SPACER SYSTEM
- K103797 — K2M COCR WIRE
- K103440 — EVEREST SPINAL SYSTEM
- K103169 — ALEUTTIAN
- K103232 — CASPIAN SPINAL SYSTEM
- K101084 — CASPIAN SPINAL SYSTEM
- K100851 — RANGE SPINAL SYSTEM
- K101302 — ALEUTIAN IBF SYSTEM
- K092474 — PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
- K092211 — CHESAPEAKE SPINAL SYSTEM
- K100061 — CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
- K093534 — MODIFICATION TO CASPIAN SPINAL SYSTEM
- K092640 — CASPIAN SPINAL SYSTEM
- K091253 — THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
- K082698 — ALEUTIAN IBF SYSTEM
- K080611 — MESA SPINAL SYSTEM
- K082769 — MESA AND RANGE SPINAL SYSTEMS
- K081380 — THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
- K081107 — CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
- K081381 — RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
- K080792 — K2M COCR ROD
- K080302 — CAYMAN BUTTRESS PLATE SYSTEM
- K080024 — ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
- K072914 — NATURAL BRIDGE LP TRANSVERSE CONNECTORS
- K070229 — RANGE SPINAL SYSTEM
- K063399 — ALEUTIAN SPACER SYSTEM
- K063544 — MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.