FDA Product Code
FDA Product Code NKB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 914 records · page 1 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261217 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | 2026-10-02 | Special | PDF ↗ |
| K263062 | NOVIX Pedicle Screw System | Tdm Co., Ltd. | 2026-10-01 | Special | PDF ↗ |
| K262712 | Duet Spinal Fixation System | Duet Spine Holdings, LLC | 2026-09-30 | Traditional | PDF ↗ |
| K263172 | SAS MIS Pelvic Incidence Rods | Spinal Alignment Solutions, Inc. | 2026-09-30 | Special | PDF ↗ |
| K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | 2026-09-27 | Traditional | PDF ↗ |
| K262067 | iFuse Granite Onyx Implant System | SI-BONE, Inc. | 2026-09-23 | Traditional | PDF ↗ |
| K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-09-17 | Traditional | PDF ↗ |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | 2026-09-14 | Traditional | PDF ↗ |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-09-04 | Special | PDF ↗ |
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026-07-24 | Traditional | PDF ↗ |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co., Ltd. | 2026-07-24 | Traditional | PDF ↗ |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | 2026-07-14 | Traditional | PDF ↗ |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-07-01 | Special | PDF ↗ |
| K253045 | Socko Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026-06-17 | Traditional | PDF ↗ |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | 2026-06-09 | Traditional | PDF ↗ |
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 | Traditional | PDF ↗ |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | Globus Medical, Inc. | 2026-05-07 | Traditional | PDF ↗ |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026-05-05 | Special | PDF ↗ |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026-05-01 | Traditional | PDF ↗ |
| K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 | Traditional | PDF ↗ |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026-04-28 | Traditional | PDF ↗ |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 | Traditional | PDF ↗ |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026-04-16 | Traditional | PDF ↗ |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-04-03 | Special | PDF ↗ |
| K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | 2026-02-24 | Traditional | PDF ↗ |
| K253169 | Duet Spinal Fixation System | Box Spine, LLC | 2026-02-23 | Traditional | PDF ↗ |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 | Traditional | PDF ↗ |
| K252461 | Swedge Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026-01-13 | Traditional | PDF ↗ |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026-01-07 | Special | PDF ↗ |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 | Special | PDF ↗ |
| K253093 | Vital Spinal Fixation System | Highridge Medical, LLC | 2025-12-17 | Traditional | PDF ↗ |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025-12-17 | Special | PDF ↗ |
| K252729 | Universal Spinal System | Double Medical Technology, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | 2025-10-24 | Traditional | PDF ↗ |
| K253335 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 | Special | PDF ↗ |
| K253249 | TriALTIS Spine System | Medos International SARL | 2025-10-21 | Special | PDF ↗ |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2025-10-21 | Traditional | PDF ↗ |
| K242827 | A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. | 2025-10-20 | Traditional | PDF ↗ |
| K253331 | PressON Spinal Fixation System | Nexus Spine | 2025-10-14 | Special | PDF ↗ |
| K252437 | JAZZ Spinal System | Implanet | 2025-08-28 | Special | PDF ↗ |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025-07-08 | Special | PDF ↗ |
| K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025-07-01 | Special | PDF ↗ |
| K250908 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | 2025-06-18 | Traditional | PDF ↗ |
| K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments | Ht Medical D.B.A. Xenix Medical | 2025-06-12 | Traditional | PDF ↗ |
| K251131 | Annex® 2 Adjacent Level System | Spine Wave, Inc. | 2025-06-06 | Traditional | PDF ↗ |
| K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | 2025-05-08 | Traditional | PDF ↗ |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System | Eminent Spine | 2025-04-28 | Traditional | PDF ↗ |
| K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | 2025-03-27 | Traditional | PDF ↗ |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | 2025-02-27 | Traditional | PDF ↗ |
| K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025-02-21 | Traditional | PDF ↗ |
| K243908 | Tiger 2 System | Zavation Medical Products, LLC | 2025-02-03 | Traditional | PDF ↗ |
| K243249 | TriALTIS Spine System | Medos International SARL | 2025-01-17 | Traditional | PDF ↗ |
| K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025-01-15 | Traditional | PDF ↗ |
| K243259 | MASADA Modular Spinal Fixation System | Astura Medical | 2025-01-07 | Traditional | PDF ↗ |
| K243693 | NEO Pedicle Screw System | Neo Medical SA | 2024-12-23 | Special | PDF ↗ |
| K242297 | Reform Pedicle Screw System | Precision Spine, Inc. | 2024-12-17 | Traditional | PDF ↗ |
| K243281 | LOCK-IN Spinal Fixation System | Lock-In USA Corp | 2024-12-13 | Traditional | PDF ↗ |
| K231655 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2024-11-26 | Special | PDF ↗ |
| K242764 | MediRod Pedicle Screw System | Cmf Medicon Surgical, Inc. | 2024-11-13 | Traditional | PDF ↗ |
| K243004 | Xpine Spinal Fixation System | Jeil Medical Corporation | 2024-11-08 | Traditional | PDF ↗ |
| K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2024-11-05 | Traditional | PDF ↗ |
| K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions, Inc. | 2024-10-28 | Traditional | PDF ↗ |
| K243007 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2024-10-23 | Special | PDF ↗ |
| K242899 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | 2024-10-17 | Special | PDF ↗ |
| K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt. , Ltd. | 2024-10-10 | Traditional | PDF ↗ |
| K241657 | MSFX MIKRON SPINAL FIXATION SYSTEM | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-09-30 | Traditional | PDF ↗ |
| K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2024-09-09 | Traditional | PDF ↗ |
| K242042 | TriALTIS Spine System | Medos International SARL | 2024-09-09 | Traditional | PDF ↗ |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw System | Eminent Spine | 2024-09-03 | Special | PDF ↗ |
| K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | 2024-08-30 | Traditional | PDF ↗ |
| K241892 | Cortera Spinal Fixation System | Xtant Medical Holdings, Inc. | 2024-08-02 | Traditional | PDF ↗ |
| K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2024-08-01 | Traditional | PDF ↗ |
| K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal | 2024-07-26 | Traditional | PDF ↗ |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024-07-24 | Special | PDF ↗ |
| K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K240963 | Spinal System | Teslake, Inc. | 2024-06-06 | Traditional | PDF ↗ |
| K241258 | Ingenix Spinal System | Ingenium Spine | 2024-06-04 | Special | PDF ↗ |
| K241276 | Vector Pedicle Screw System | Innovasis, Inc. | 2024-05-20 | Traditional | PDF ↗ |
| K240685 | Salvo® Spine System | Spine Wave, Inc. | 2024-05-06 | Traditional | PDF ↗ |
| K240392 | JAZZ Spinal System | Implanet | 2024-05-06 | Traditional | PDF ↗ |
| K240526 | POWEReam Xia/Serrato | Stryker Instruments | 2024-04-29 | Traditional | PDF ↗ |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | 2024-04-26 | Special | PDF ↗ |
| K240846 | 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 | CarboFix Orthopedics , Ltd. | 2024-04-25 | Special | PDF ↗ |
| K232566 | 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 | SeaSpine Orthopedics Corporation | 2024-04-19 | Traditional | PDF ↗ |
| K240737 | G Surgical Marksman MIS System | G Surgical, LLC | 2024-04-05 | Special | PDF ↗ |
| K240350 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | 2024-04-03 | Traditional | PDF ↗ |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024-03-27 | Traditional | PDF ↗ |
| K240539 | Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-03-15 | Special | PDF ↗ |
| K232607 | 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM | Solco Biomedical Copany India Private Limited | 2024-02-27 | Traditional | PDF ↗ |
| K232628 | VADER® Pedicle System | Icotec AG | 2024-02-26 | Traditional | PDF ↗ |
| K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024-02-13 | Traditional | PDF ↗ |
| K233960 | INNOVERSE Spinal System | Innosys Co., Ltd. | 2024-02-06 | Traditional | PDF ↗ |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics , Ltd. | 2024-01-10 | Special | PDF ↗ |
| K233300 | POWEReam 1/4 Drive | Stryker Instruments | 2023-12-26 | Traditional | PDF ↗ |
| K233455 | ARx MIS Spinal Screw System | Life Spine, Inc. | 2023-12-12 | Traditional | PDF ↗ |
| K233684 | TriALTIS Spine System | Medos International SARL | 2023-12-12 | Special | PDF ↗ |
| K232719 | ProMIS Extension Rod System | Premia Spine, Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 2023-11-21 | Traditional | PDF ↗ |
| K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023-11-16 | Traditional | PDF ↗ |
| K233234 | PressON Spinal Fixation System | Nexus Spine, LLC | 2023-10-26 | Special | PDF ↗ |
Product code NKB · Class II · Orthopedic. Data: openFDA.