FDA.report

K2M, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30047741183008599177K2M, INC.1N2026-01-01600 Hope Pkwy SE Leesburg VA US 20175
30047741183008599177K2M, INC.1N2020-04-25600 Hope Pkwy SE Leesburg VA US 20175

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3389941895902464K260546Q Pedicle InstrumentsOLO2026-03-17
3389941275126688K253545Vulcan Spinal SystemNKB2026-02-10
3389941734455954K252873Q Interbody InstrumentsOLO2026-02-06
3389941446604124K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MIKWQ2024-11-07
3389941392543892K241517Q Guidance System; Mako Spine System;OLO2024-08-27
3389941866016557K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary HandpieceOLO2024-06-06
3389941956787222K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L SpacerODP2023-02-14
3389941948042226K211320CAPRI Corpectomy Cage SystemPLR2022-02-24
3389941354533345K203205Navigated Spine InstrumentsOLO2021-03-23
3389941694846275K202528Cannulated Power Driver AttachmentNKB2020-10-26
3389941325526060K201006K2M Navigation InstrumentsOLO2020-08-07
3389941876402045K193129Yukon OCT Spinal SystemNKG2020-02-07
3389941157068738K190584CAYMAN LP Plate SystemKWQ2019-05-15
2250061394180958K190584CAYMAN LP Plate SystemKWQ2019-05-15
2250061335231462K190179SAHARA Stabilization SystemOVD2019-10-03
3389941818894635K190179SAHARA Stabilization SystemOVD2019-10-03
3389941077442970K182182YUKON OCT Spinal SystemNKG2018-11-15
2250061119721921K182182YUKON OCT Spinal SystemNKG2018-11-15
3389941494285152K181890Brainlab Compatible K2M Navigation InstrumentsOLO2018-11-09
2250061956648345K181890Brainlab Compatible K2M Navigation InstrumentsOLO2018-11-09
2250061562713886K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal SystemNKG2018-10-05
3389941768716169K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal SystemNKG2018-10-05
2250061165341220K181188EVEREST Spinal SystemNKB2018-05-30
3389941454855752K181188EVEREST Spinal SystemNKB2018-05-30
2250061184836446K181119Range (Denali and Mesa) Spinal SystemsNKB2018-06-26
3389941390273309K181119Range (Denali and Mesa) Spinal SystemsNKB2018-06-26
2250061641265273K180777K2M Expandable Interbody SystemMAX2018-08-03
2250061320361604K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemMQP2018-11-28
3389941462701123K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemMQP2018-11-28
2250061163755380K180376K2M Patient Specific RodsNKB2018-04-05
3389941702011974K180376K2M Patient Specific RodsNKB2018-04-05
2250061072086569K173508Everest Spinal SystemNKB2018-01-09
3389941478776837K173508Everest Spinal SystemNKB2018-01-09
3389941596048167K172941CASCADIA Interbody SystemOVD2018-02-12
2250062052258234K172941CASCADIA Interbody SystemOVD2018-02-12
3389941440181713K172104Ozark(tm) Cervical Plate SystemKWQ2017-08-23
2250061468223202K172104Ozark(tm) Cervical Plate SystemKWQ2017-08-23
2250061252957157K172009Cascadia Interbody SystemMAX2017-12-14
3389941943877909K172009Cascadia Interbody SystemMAX2017-12-14
2250061172303095K171832Range/Denali/Mesa Spinal SystemNKB2017-09-14
3389941876388742K171832Range/Denali/Mesa Spinal SystemNKB2017-09-14
2250061180680285K171704CAPRI Corpectomy Cage SystemMQP2017-08-31
3389941803000592K171704CAPRI Corpectomy Cage SystemMQP2017-08-31
2250061049058513K171556K2M Navigation InstrumentsOLO2018-01-16
3389941394672776K171556K2M Navigation InstrumentsOLO2018-01-16
2250061070662363K171444YUKON OCT Spinal SystemNKG2017-08-08
3389941159470636K171444YUKON OCT Spinal SystemNKG2017-08-08
3389941078971699K171321K2M Navigation InstrumentsOLO2017-08-30
2250061206975073K171321K2M Navigation InstrumentsOLO2017-08-30
3389941105047049K171097MOJAVE Expandable Interbody SystemMAX2017-05-10
2250061203678287K171097MOJAVE Expandable Interbody SystemMAX2017-05-10
3389941217804876K170055CAPRI Corpectomy Cage SystemMQP2017-04-13
2250061266082052K170055CAPRI Corpectomy Cage SystemMQP2017-04-13
2250061086758592K163364MOJAVE Expandable Interbody SystemMAX2017-03-15
3389941471434070K163364MOJAVE Expandable Interbody SystemMAX2017-03-15
3389941661165230K162664Pyrenees Cervical Plate SystemKWQ2016-10-07
2250062000791240K162664Pyrenees Cervical Plate SystemKWQ2016-10-07
3389941130013515K162264Cascadia Interbody SystemMAX2016-09-21
2250061919332895K162264Cascadia Interbody SystemMAX2016-09-21
2250061368696576K161369EVEREST Spinal SystemNKB2016-07-21
3389941521707365K161369EVEREST Spinal SystemNKB2016-07-21
3389941180349316K161332NILE Proximal Fixation Spinal SystemOWI2017-04-05
2250061383405875K161332NILE Proximal Fixation Spinal SystemOWI2017-04-05
2250061245183217K161028K2M Growing Spine SystemPGM2016-07-22
3389941872457509K161028K2M Growing Spine SystemPGM2016-07-22
3389941248693469K160547Cascadia Interbody SystemMAX2016-03-24
2250061698333140K160547Cascadia Interbody SystemMAX2016-03-24
2250061273163729K160208NILE Alternative Fixation Spinal SystemOWI2016-03-18
3389942019126243K160208NILE Alternative Fixation Spinal SystemOWI2016-03-18
3389941423663408K160125Cascadia Interbody SystemODP2016-04-22
2250061532146871K160125Cascadia Interbody SystemODP2016-04-22
3389941334754786K153526Pyrenees Cervical Plate SystemKWQ2016-04-27
2250061799784547K153526Pyrenees Cervical Plate SystemKWQ2016-04-27
2250061717919251K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemNKG2016-02-16
3389942032314938K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemNKG2016-02-16
3389941128980960K153031RANGE/DENALI/MESA Spinal SystemNKB2015-11-17
2250061271953859K153031RANGE/DENALI/MESA Spinal SystemNKB2015-11-17
3389941309726191K152872K2M Fenestrated Tap SystemKNW2016-01-05
2250061499994969K152872K2M Fenestrated Tap SystemKNW2016-01-05
3389941428942413K152568C-VBRPLR2016-02-11
2250062035225813K152568C-VBRPLR2016-02-11
2250061860607490K152281Pyrenees Cervical Plate SystemKWQ2015-09-24
3389942001113546K152281Pyrenees Cervical Plate SystemKWQ2015-09-24
2250061503245037K152015Pyrenees Cervical Plate SystemKWQ2015-09-04
3389941512864507K152015Pyrenees Cervical Plate SystemKWQ2015-09-04
3389941333531885K151727Everest Spinal SystemNKB2015-09-17
2250061641586778K151727Everest Spinal SystemNKB2015-09-17
3389941622269872K151481Sahara Stabilization SystemOVD2015-12-21
2250061879249229K151481Sahara Stabilization SystemOVD2015-12-21
2250061459732610K151216Everest Spinal SystemNKB2015-08-10
3389941830648512K151216Everest Spinal SystemNKB2015-08-10
2250061269335698K150983Pyrenees Cervical Plate SystemKWQ2015-07-14
3389941777254708K150983Pyrenees Cervical Plate SystemKWQ2015-07-14
3389941359144282K150481Cascadia Interbody SystemMAX2015-08-20
2250061904770704K150481Cascadia Interbody SystemMAX2015-08-20
3389941315951172K150325Range/Denali/Mesa Spinal SystemNKB2015-03-31
2250061669526884K150325Range/Denali/Mesa Spinal SystemNKB2015-03-31
3389941799949437K143350Nile Alternative FixationOWI2015-02-25
2250061951936482K143350Nile Alternative FixationOWI2015-02-25
3389941395341926K143334Range/Denali/Mesa Spinal SystemNKB2015-01-09
2250061396441679K143334Range/Denali/Mesa Spinal SystemNKB2015-01-09
3389941300407464K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP2014-12-22
2250061810448617K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP2014-12-22
3389941688873981K142487Chesapeake Stabilization SystemOVD2015-05-07
2250061821747887K142487Chesapeake Stabilization SystemOVD2015-05-07
3389941342828620K142360Everest Spinal SystemNKB2015-01-21
2250061897468876K142360Everest Spinal SystemNKB2015-01-21
2250062007074712K142212Pyrenees Cervical Plate SystemKWQ2015-05-01
3389942063527794K142212Pyrenees Cervical Plate SystemKWQ2015-05-01
2250061550458930K142016CAPRIMQP2014-11-06
3389941998926412K142016CAPRIMQP2014-11-06
2250061111504512K141873RANGE/MESA/DENALI SPINAL SYSTEMNKB2014-09-08
3389941434370184K141873RANGE/MESA/DENALI SPINAL SYSTEMNKB2014-09-08
2250061186100611K141284CASPIAN SPINAL SYSTEMKWP2014-07-23
3389941938877240K141284CASPIAN SPINAL SYSTEMKWP2014-07-23
3389941263098039K141147RANGE SPINAL SYSTEMNKB2014-06-03
2250061838971211K141147RANGE SPINAL SYSTEMNKB2014-06-03
2250061597698498K140765RANGE/MESA/DENALI SPINAL SYSTEMNKB2014-07-10
3389941697916923K140765RANGE/MESA/DENALI SPINAL SYSTEMNKB2014-07-10
3389941116076521K140529EVEREST SPINAL SYSTEMNKB2014-05-22

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NKB382026-02-10
KWQ372024-11-07
MNI302013-11-20
KWP242014-12-22
MAX232018-08-03
MQP162018-11-28
OVD142019-10-03
OLO122026-03-17
OSH122013-08-30
NKG92020-02-07
ODP72023-02-14
OWI62017-04-05
MNH62012-06-27
MQV42010-03-24
PLR32022-02-24
PGM22016-07-22
KNW22016-01-05
OVE22011-08-24
JDQ22011-05-20

PMA

PMN

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