Thoracolumbosacral Pedicle Screw System
FDA product code NKB · 809 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3070
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2003-02-25 – 2026-09-27
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
NKB
2026-09-27
NKB
2026-09-23
iFuse Granite Onyx™ Implant System
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2026-09-17
FRAXION Spinal Fixation System
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2026-07-24
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2026-07-24
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2026-07-14
Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
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2026-07-01
KHEIRON® Spinal Fixation System, including patient specific K-ROD
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2026-06-17
“Socko” Vimax Spinal Fixation System
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2026-06-09
ChanPin Pedicle Screw Spinal System
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2026-05-15
Varion Thoracolumbar Fixation System
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2026-05-07
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
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NKB
2026-05-05
AccelFix Spinal Fixation System
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NKB
2026-05-01
PERLA® TL Posterior Thoraco-lumbar Fixation System
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NKB
2026-04-29
LEO Spinal System
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NKB
2026-04-28
M.U.S.T. Pedicle Screw System - Extension
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NKB
2026-04-21
CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System
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NKB
2026-04-16
ARx® SAI Implant System
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NKB
2026-04-03
KHEIRON® Spinal Fixation System, including patient specific K-ROD
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NKB
2026-02-24
OSTEOMNI SPINAL FIXATION SYSTEM
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NKB
2026-02-23
Duet™ Spinal Fixation System
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NKB
2026-02-10
Vulcan Spinal System
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NKB
2026-01-13
Swedge™ Pedicle Screw Fixation System Bezier Rod
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NKB
2026-01-07
KHEIRON® Spinal Fixation System, including patient specific K-ROD
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NKB
2026-01-07
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
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NKB
2025-12-17
KHEIRON® Spinal Fixation System, including patient specific K-ROD
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NKB
2025-12-17
Vital™ Spinal Fixation System
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NKB
2025-11-18
Universal Spinal System
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NKB
2025-10-24
CD Horizon™ Spinal System
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NKB
2025-10-24
Fule Spinal Fixation System
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NKB
2025-10-21
TriALTIS™ Spine System
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NKB
2025-10-21
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
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NKB
2025-10-20
A8 INTEGR8™ Porous Pedicle Screws
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NKB
2025-10-14
PressON Spinal Fixation System
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NKB
2025-08-28
JAZZ Spinal System
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NKB
2025-07-08
KHEIRON® Spinal Fixation System, including patient specific K-ROD
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NKB
2025-07-01
Momentum® Posterior Spinal Fixation System
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NKB
2025-06-18
Virata Spinal Fixation System
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NKB
2025-06-12
RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
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NKB
2025-06-06
Annex® 2 Adjacent Level System
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NKB
2025-05-08
COLONNADE Posterior Screw Fixation System
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NKB
2025-04-28
Eminent Spine 3D Titanium Pedicle Screw System
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NKB
2025-03-27
HC Biologics Osteopoint Spinal Fixation System
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NKB
2025-02-27
VADER® Pedicle System and VADER®one Pedicle System
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NKB
2025-02-21
Primus Spinal Fixation System
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NKB
2025-02-03
Tiger 2 System
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NKB
2025-01-17
TriALTIS™ Spine System
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NKB
2025-01-15
EffortMed Spinal Fixation System
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NKB
2025-01-07
MASADA Modular Spinal Fixation System
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NKB
2024-12-23
NEO Pedicle Screw System™
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NKB
2024-12-17
Reform Pedicle Screw System
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NKB
2024-12-13
LOCK-IN Spinal Fixation System
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NKB
2024-11-26
4CIS® Chiron Spinal Fixation System
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NKB
2024-11-13
MediRod Pedicle Screw System
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NKB
2024-11-08
Xpine Spinal Fixation System
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NKB
2024-11-05
CarboClear® Hybrid Pedicle Screw System
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NKB
2024-10-28
Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
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NKB
2024-10-23
CD Horizon™ Spinal System
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NKB
2024-10-17
NOVA Minimally Invasive System
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NKB
2024-10-10
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
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NKB
2024-09-30
MSFX MIKRON SPINAL FIXATION SYSTEM
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NKB
2024-09-09
TriALTIS™ Spine System
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NKB
2024-09-09
Pitkar Spinal Pedicle Screw System
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NKB
2024-09-03
Eminent Spine Scoliosis Deformity Pedicle Screw System
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NKB
2024-08-30
Orthopeasia Spinal Fixation System
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NKB
2024-08-02
Cortera™ Spinal Fixation System
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NKB
2024-08-01
CarboClear® X Pedicle Screw System
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NKB
2024-07-26
Pantheon Pedicle Screw and Iliac Bolt Fixation System
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NKB
2024-07-24
Erisma® Lp Spinal Fixation System; Erisma® LP MIS
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NKB
2024-06-21
Invictus® Small Stature Spinal Fixation System
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NKB
2024-06-06
Spinal System
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NKB
2024-06-04
Ingenix Spinal System
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NKB
2024-05-20
Vector™ Pedicle Screw System
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NKB
2024-05-06
Salvo® Spine System
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NKB
2024-05-06
JAZZ Spinal System
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NKB
2024-04-29
POWEReam Xia/Serrato
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NKB
2024-04-26
Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
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NKB
2024-04-25
CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
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NKB
2024-04-19
NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
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NKB
2024-04-05
G Surgical Marksman MIS System
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NKB
2024-04-03
AnyPlus II Spinal Fixation System
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NKB
2024-03-27
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
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NKB
2024-03-15
Vital™ Spinal Fixation System
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NKB
2024-02-27
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
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NKB
2024-02-26
VADER® Pedicle System
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NKB
2024-02-13
M.U.S.T. Pedicle Screw System - Extension
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NKB
2024-02-06
INNOVERSE Spinal System
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NKB
2024-01-10
CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
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NKB
2023-12-26
POWEReam 1/4 Drive
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NKB
2023-12-12
TriALTIS™ Spine System
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NKB
2023-12-12
ARx MIS Spinal Screw System
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NKB
2023-11-21
ProMIS Extension Rod System
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NKB
2023-11-21
Mini-OSTEO Pedicle Fixation System
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NKB
2023-11-16
MASADA Modular Spinal Fixation System
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NKB
2023-10-26
PressON Spinal Fixation System
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NKB
2023-10-26
ANAX™ 5.5 Spinal System
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NKB
2023-10-25
PERLA® TL Posterior Thoraco-lumbar Fixation System
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NKB
2023-10-24
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
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NKB
2023-10-23
Ripley Spinal Screw System by SAGICO
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