510(k) K260786
- Device
- KHEIRON® Spinal Fixation System, including patient specific K-ROD
- Applicant
- S.M.A.I.O
- 510(k) number
- K260786
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-03
- Date received
- 2026-03-10
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jean-Charles ROUSSOULY
- Address
- 2 Pl. Berthe Morisot Saint-Priest FR 69800 69800
FDA Registration Numbers
- 1450662
- 3021006165
- 3010128826
- 3015487912
- 3014252644
- 3001239363
- 3004464325
- 2183744
- 3023852420
- 1834331
- 3003541440
- 3013756169
- 3013194153
- 3009962553
- 1833824
- 3009504230
- 3000170817
- 1319660
- 3008754074
- 3014268622
- 3021945817
- 3007700286
- 1045254
- 3012429289
- 9612277
- 3010863450
- 3019767615
- 1531050
- 3006128100
- 3019837678
- 1225838
- 1030489
- 3029933740
- 3004719693
- 1649379
- 2183449
- 3039169546
- 3004024955
- 9617616
- 3012120772
- 3010365473
- 3005083075
- 3009887475
- 3022518322
- 3023138345
- 1221053
- 3010047454
- 3013546462
- 9615014
- 3009973505
- 3009554293
- 2087234
- 2032112
- 3012447612
- 3012599928
- 9616062
- 9611827
- 3011513267
- 1530390
- 2531195
- 3006017180
- 1835296
- 3007887127
- 2029275
- 9615128
- 3004049923
- 3008992889
- 3010531060
- 3004893332
- 3009988302
- 1528646
- 1722511
- 3011181154
- 3005226664
- 3016084569
- 3009165919
- 3011277306
- 3003526896
- 3019356409
- 8010468
- 3015967359
- 3010370500
- 3018780416
- 3004788213
- 3010120148
- 3009144915
- 8043792
- 3015383864
- 3007485169
- 1836357
- 3007014520
- 3018094310
- 3013111980
- 1423662
- 3009540749
- 3004176895
- 3006404071
- 3006639944
- 3010440433
- 3010197239
- 3011964577
- 1000461041
- 1835831
- 2183946
- 2032098
- 3000203391
- 3010197224
- 3017155536
- 1833920
- 3005061536
- 3011221483
- 3011796723
- 9610612
- 3002808145
- 1526439
- 3009106092
- 2532027
- 3010162973
- 3012491394
- 3007675554
- 2135156
- 3010143171
- 3004153896
- 3007923096
- 3005031160
- 3012770122
- 3013846070
- 3008285983
- 3008110533
- 1043214
- 3005739886
- 3006378738
- 3010123256
- 3003935342
- 2032093
- 9615766
- 3011015572
- 3008850074
- 3011170410
- 3009882462
- 3010329663
- 3005596514
- 3004638532
- 3010646402
- 3014937101
- 1527105
- 3008812560
- 1828464
- 1835251
- 1056553
- 3011874600
- 2647346
- 3009173317
- 3007997036
- 3037407500
- 3017565094
- 3010160527
- 3015443158
- 2134947
- 1224360
- 3007766698
- 3009971621
- 3011556898
- 3009631939
- 1720929
- 3043543260
- 2027467
- 1222773
- 3010462278
- 3017036472
- 3014003062
- 1530530
- 3013422236
- 1531174
- 1835444
- 9610726
- 3014725904
- 1000432246
- 1226544
- 2249608
- 3016050940
- 3009049161
- 3010009693
- 3022159082
- 3010370880
- 3015399803
- 9617544
- 3006563559
- 9616944
- 1824313
- 3011656326
- 3006783837
- 3011187779
- 3011577940
- 3009882675
- 3014273424
- 3007539489
- 3004638600
- 3031261833
- 3007353762
- 3010363503
- 1424263
- 3008959459
- 3008583793
- 3012711663
- 3006984710
- 1833506
- 2133928
- 3005180920
- 3012131184
- 3009973699
- 3007334927
- 2134470
- 3010120339
- 3009941480
- 3009380093
- 3015212339
- 3025603301
- 2028632
- 3012994232
- 3014763043
- 3013034344
- 3041915189
- 3004635447
- 3038505140
- 3043620689
- 3014680795
- 3010041993
- 3009509485
- 3015831087
- 9611610
- 3016438694
- 3006493760
- 3009973336
- 3010097171
- 3022472578
- 3043234953
- 3007604895
- 3009217531
- 3030412764
- 3005562917
- 1057425
- 3011500362
- 3010041499
- 2031966
- 3009957608
- 3009732568
- 3005076207
- 3008526708
- 1526534
- 1828288
- 3005360851
- 3007125392
- 3003120897
- 3008455034
- 3002808227
- 1000517406
- 3005497913
- 9615021
- 3008102042
- 3031240334
- 3015941638
- 1000577893
- 3011795235
- 1221763
- 1047843
- 3007738812
- 3013491327
- 3008114965
- 3015426608
- 3016261131
- 3003525643
- 3008868758
- 3010178296
- 3014678447
- 3009110133
- 3015869121
- 3033509898
- 3036756245
- 2244478
- 3009050824
- 2134285
- 3004748528
- 3002806603
- 3005706667
- 3007441485
- 9611813
- 3005874553
- 2531477
- 3010663372
- 3006846753
- 3014387294
- 3007728266
- 3009959868
- 1529009
- 2648666
- 3008262872
- 1000200989
- 3009241418
- 2530808
- 3010057495
- 3012401682
- 3014655115
- 3010041430
- 1000493591
- 3010665091
- 3004717358
- 3006791286
- 1824199
- 3003855635
- 3011301313
- 1319429
- 3004142400
- 1223434
- 1043653
- 3017435639
- 3026311512
- 3010370554
- 3010032903
- 3010175289
- 3006460162
- 3014129047
- 3010120104
- 3005819474
- 3021948057
- 3010303097
- 1424434
- 3012428435
- 9611390
- 3016443334
- 3010509633
- 3002976036
- 8010099
- 3005641619
- 3010531069
- 8020776
- 2133687
- 3004941535
- 9612420
- 1649518
- 9681465
- 3017528621
- 3009446038
- 1835572
- 3010120135
- 3020282716
- 3009417901
- 3006082533
- 3000270450
- 3014938863
- 3013548554
- 3005827567
- 3009888740
- 3003477135
- 3014257776
- 3016496998
- 2648623
- 3006513362
- 3040335671
- 3002807561
- 1834379
- 3013011598
- 3007279845
- 1935627
- 3008534770
- 3011489618
- 3013514648
- 3009051471
- 1220477
- 3015876273
- 3017780544
- 8010944
- 3004499989
- 1643817
- 3009380063
- 9617297
- 3010123206
- 3009998573
- 3006356043
- 3010049501
- 3003639920
- 3018210489
- 3006217744
- 3005677016
- 3010866843
- 3007993775
- 3003387384
- 1066368
- 3015440604
- 3007922509
- 3017597868
- 3019878714
- 3012764194
- 3013055499
- 9611274
- 3011390763
- 3015869493
- 3004188066
- 3009169872
- 3004774118
- 3003761012
- 3027807601
- 3009381600
- 3012381896
- 3005823819
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code NKB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | Globus Medical, Inc. | 2026-05-07 |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026-05-05 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026-05-01 |
| K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026-04-28 |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026-04-16 |
| K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | 2026-02-24 |
| K253169 | Duet Spinal Fixation System | Box Spine, LLC | 2026-02-23 |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 |
| K252461 | Swedge Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026-01-13 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-01-07 |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025-12-17 |