510(k) K233684
- Device
- TriALTIS? Spine System
- Applicant
- Medos International SARL
- 510(k) number
- K233684
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-12
- Date received
- 2023-11-16
- 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
- No
Applicant Contact#
- Contact
- Denielle Smith
- Address
- Chemin-Blanc 38 Le Locle CH 2400 2400
FDA Registration Numbers#
- 3015869493
- 1833920
- 1222773
- 3002808145
- 3015941638
- 1000517406
- 2648666
- 3003855635
- 1047843
- 9610726
- 1226544
- 3021945817
- 3010646402
- 3009417901
- 3009217531
- 3005874553
- 3017435639
- 3016084569
- 1221053
- 3017036472
- 9681465
- 3009380063
- 3019837678
- 2531195
- 1223434
- 3010162973
- 3043234953
- 3008285983
- 3006513362
- 1835251
- 3007014520
- 3010531069
- 1066368
- 3008526708
- 3018780416
- 3004176895
- 3006791286
- 1643817
- 3011277306
- 3006984710
- 3009882675
- 3010120326
- 3012711663
- 8020776
- 3037407500
- 3004499989
- 3007334927
- 3016261131
- 1824199
- 3025603301
- 8010944
- 3014257776
- 3007485169
- 3009957608
- 3012764194
- 3010120148
- 9611390
- 1834331
- 3007922509
- 3004638532
- 3010041993
- 3005497913
- 1225838
- 1828464
- 3019878714
- 3006017180
- 3009882462
- 3009998573
- 3018094310
- 9617616
- 3006356043
- 2031966
- 9617297
- 3004142400
- 3041915189
- 9611274
- 3009971621
- 1720929
- 3014937101
Source Documents#
Other 510(k) Records For Product Code NKB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026-07-24 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | 2026-07-24 |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | 2026-07-14 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-07-01 |
| K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026-06-17 |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | 2026-06-09 |
| 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 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-04-03 |