510(k) K170266
- Device
- Palisade™ Pedicular Fixation System
- Applicant
- Spineology Inc.
- 510(k) number
- K170266
- Product code
- NKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-14
- Date received
- 2017-01-27
- Regulation
- 888.3070
- Classification name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jacqueline Hauge
- Address
- 7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128
FDA Registration Numbers#
- 3037407500
- 3010041430
- 3006846753
- 3014268622
- 1057425
- 3021006165
- 3009971621
- 3012429289
- 3014725904
- 1030489
- 3015440604
- 3007014520
- 3010531069
- 3002976036
- 1000493591
- 1835251
- 1834331
- 3004638532
- 3005827567
- 3015869121
- 2183946
- 3010329663
- 9617297
- 1835444
- 1000461041
- 3005706667
- 3009882462
- 2244478
- 3008102042
- 3019356409
- 3021948057
- 3016261131
- 3013491327
- 1424434
- 3034676720
- 3009217531
- 3003935342
- 3039169546
- 3010365473
- 3011221483
- 3009169872
- 1833920
- 3005562917
- 3014937101
- 3033509898
- 3000170817
- 9611390
- 2531477
- 3025603301
- 3009973699
- 3003541440
- 3002807561
- 9617616
- 8010099
- 3017780544
- 3010370554
- 3010128826
- 3011390763
- 3043234953
- 3015869493
- 9610612
- 3006984710
- 3008868758
- 3010665091
- 1824313
- 1835296
- 3016050940
- 3009380063
- 3014257776
- 3010097171
- 1530390
- 3003639920
- 3020282716
- 3013011598
- 9616944
- 3011656326
- 1935627
- 3007993775
- 3012447612
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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