510(k) K150390
- Device
- Nautilus Spinal System
- Applicant
- LIFE SPINE, INC.
- 510(k) number
- K150390
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-16
- Date received
- 2015-02-18
- 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
- RANDY LEWIS
- Address
- 13951 S Quality Dr. Huntley IL US 60142 60142
FDA Registration Numbers#
- 3003541440
- 1834379
- 3004142400
- 9612420
- 3015212339
- 3010531060
- 3012599928
- 1720929
- 3014763043
- 3017565094
- 1000200989
- 1649379
- 3007353762
- 3014129047
- 3005031160
- 3013111980
- 1530390
- 3006783837
- 3012120772
- 3010197239
- 3010370500
- 3012711663
- 3010123256
- 3008526708
- 3014678447
- 3004717358
- 3010663372
- 3009631939
- 3009381600
- 2530808
- 3010128826
- 3005180920
- 3014003062
- 3015399803
- 2648623
- 3017036472
- 3031240334
- 3043543260
- 3007922509
- 3010462278
- 3030412764
- 3010120326
- 3013756169
- 2648666
- 3010049501
- 3010032903
- 1221053
- 2531195
- 3010123206
- 3011796723
- 2249608
- 2133928
- 1835251
- 3007279845
- 3011301313
- 3014655115
- 3010365473
- 3010160527
- 2027467
- 3025603301
- 3000170817
- 1043214
- 3009217531
- 9615021
- 3012994232
- 3016438694
- 2135156
- 3021006165
- 1221763
- 3002808227
- 3008534770
- 1319660
- 1835831
- 3006017180
- 3002808145
- 3010863450
- 3015440604
- 3009732568
- 3011390763
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 |
Legacy Summary#
summary
FDA Review#
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