| Tiger 2 System (K253943) | Zavation Medical Products, LLC | 2026-07-24 |
| QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (K260362) | MANTIZ Co., Ltd. | 2026-07-24 |
| Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (K261284) | Alphatec Spine, Inc. | 2026-07-14 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253802) | S.M.A.I.O | 2026-07-01 |
| “Socko” Vimax Spinal Fixation System (K253045) | Socko Medical Co., Ltd. | 2026-06-17 |
| ChanPin Pedicle Screw Spinal System (K251251) | Chanpin Medtak Co., Ltd. | 2026-06-09 |
| Varion Thoracolumbar Fixation System (K260989) | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 |
| SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (K253739) | Globus Medical, Inc. | 2026-05-07 |
| AccelFix Spinal Fixation System (K261130) | L&K BIOMED Co., Ltd. | 2026-05-05 |
| PERLA® TL Posterior Thoraco-lumbar Fixation System (K253966) | Spineart SA | 2026-05-01 |
| LEO Spinal System (K252542) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 |
| M.U.S.T. Pedicle Screw System - Extension (K253940) | Medacta International S.A. | 2026-04-28 |
| CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (K260216) | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 |
| ARx® SAI Implant System (K254274) | Life Spine, Inc. | 2026-04-16 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K260786) | S.M.A.I.O | 2026-04-03 |
| OSTEOMNI SPINAL FIXATION SYSTEM (K254247) | Osteomni, Inc. | 2026-02-24 |
| Duet™ Spinal Fixation System (K253169) | Box Spine, LLC | 2026-02-23 |
| Vulcan Spinal System (K253545) | K2m, Inc. | 2026-02-10 |
| Swedge™ Pedicle Screw Fixation System Bezier Rod (K252461) | Spinal Resources, Inc. | 2026-01-13 |
| CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (K253941) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253990) | S.M.A.I.O | 2026-01-07 |
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253721) | S.M.A.I.O | 2025-12-17 |
| Universal Spinal System (K252729) | Double Medical Technology, Inc. | 2025-11-18 |
| Fule Spinal Fixation System (K252730) | Beijing Fule Science & Technology Development Co., Ltd. | 2025-10-24 |
| CD Horizon™ Spinal System (K253335) | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 |
| TriALTIS™ Spine System (K253249) | Medos International SARL | 2025-10-21 |
| OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (K252346) | Astura Medical | 2025-10-21 |
| A8 INTEGR8™ Porous Pedicle Screws (K242827) | Allumin8, Inc. | 2025-10-20 |
| PressON Spinal Fixation System (K253331) | Nexus Spine | 2025-10-14 |
| JAZZ Spinal System (K252437) | Implanet | 2025-08-28 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K251804) | S.M.A.I.O | 2025-07-08 |
| Momentum® Posterior Spinal Fixation System (K251719) | Ulrich Medical USA, Inc. | 2025-07-01 |
| Virata Spinal Fixation System (K250908) | SeaSpine Orthopedics Corporation | 2025-06-18 |
| RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (K251154) | Ht Medical D.B.A. Xenix Medical | 2025-06-12 |
| Annex® 2 Adjacent Level System (K251131) | Spine Wave, Inc. | 2025-06-06 |
| COLONNADE Posterior Screw Fixation System (K250582) | CG Bio Co., Ltd. | 2025-05-08 |
| Eminent Spine 3D Titanium Pedicle Screw System (K241663) | Eminent Spine | 2025-04-28 |
| HC Biologics Osteopoint Spinal Fixation System (K250092) | HC Biologics, LLC | 2025-03-27 |
| VADER® Pedicle System and VADER®one Pedicle System (K242900) | Icotec AG | 2025-02-27 |
| Primus Spinal Fixation System (K243916) | Spinal Elements, Inc. | 2025-02-21 |
| Tiger 2 System (K243908) | Zavation Medical Products, LLC | 2025-02-03 |
| TriALTIS™ Spine System (K243249) | Medos International SARL | 2025-01-17 |
| EffortMed Spinal Fixation System (K243946) | Effortmed, LLC | 2025-01-15 |
| MASADA Modular Spinal Fixation System (K243259) | Astura Medical | 2025-01-07 |
| NEO Pedicle Screw System™ (K243693) | Neo Medical SA | 2024-12-23 |
| Reform Pedicle Screw System (K242297) | Precision Spine, Inc. | 2024-12-17 |
| LOCK-IN Spinal Fixation System (K243281) | Lock-In USA Corp | 2024-12-13 |
| 4CIS® Chiron Spinal Fixation System (K231655) | Solco Biomedical Co., Ltd. | 2024-11-26 |
| MediRod Pedicle Screw System (K242764) | Cmf Medicon Surgical, Inc. | 2024-11-13 |
| Xpine Spinal Fixation System (K243004) | Jeil Medical Corporation | 2024-11-08 |
| CarboClear® Hybrid Pedicle Screw System (K243106) | CarboFix Orthopedics , Ltd. | 2024-11-05 |
| Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (K242350) | Spinal Alignment Solutions, Inc. | 2024-10-28 |
| CD Horizon™ Spinal System (K243007) | Medtronic Sofamor Danek USA, Inc. | 2024-10-23 |
| NOVA Minimally Invasive System (K242899) | Baui Biotech Co., Ltd. | 2024-10-17 |
| GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (K230325) | Greens Surgicals Pvt. , Ltd. | 2024-10-10 |
| MSFX MIKRON SPINAL FIXATION SYSTEM (K241657) | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-09-30 |
| Pitkar Spinal Pedicle Screw System (K240233) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2024-09-09 |
| TriALTIS™ Spine System (K242042) | Medos International SARL | 2024-09-09 |
| Eminent Spine Scoliosis Deformity Pedicle Screw System (K242069) | Eminent Spine | 2024-09-03 |
| Orthopeasia Spinal Fixation System (K240180) | Orthopeasia Co., Ltd. | 2024-08-30 |
| Cortera™ Spinal Fixation System (K241892) | Xtant Medical Holdings, Inc. | 2024-08-02 |
| CarboClear® X Pedicle Screw System (K233793) | CarboFix Orthopedics , Ltd. | 2024-08-01 |
| Pantheon Pedicle Screw and Iliac Bolt Fixation System (K241494) | Pantheon Spinal | 2024-07-26 |
| Erisma® Lp Spinal Fixation System; Erisma® LP MIS (K241863) | Clariance | 2024-07-24 |
| Invictus® Small Stature Spinal Fixation System (K241519) | Alphatec Spine, Inc. | 2024-06-21 |
| Spinal System (K240963) | Teslake, Inc. | 2024-06-06 |
| Ingenix Spinal System (K241258) | Ingenium Spine | 2024-06-04 |
| Vector™ Pedicle Screw System (K241276) | Innovasis, Inc. | 2024-05-20 |
| JAZZ Spinal System (K240392) | Implanet | 2024-05-06 |
| Salvo® Spine System (K240685) | Spine Wave, Inc. | 2024-05-06 |
| POWEReam Xia/Serrato (K240526) | Stryker Instruments | 2024-04-29 |
| Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (K240872) | Clariance | 2024-04-26 |
| 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 (K240846) | CarboFix Orthopedics , Ltd. | 2024-04-25 |
| 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 (K232566) | SeaSpine Orthopedics Corporation | 2024-04-19 |
| G Surgical Marksman MIS System (K240737) | G Surgical, LLC | 2024-04-05 |
| AnyPlus II Spinal Fixation System (K240350) | GS Medical Co., Ltd. | 2024-04-03 |
| CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (K233951) | Medtronic Sofamor Danek USA, Inc. | 2024-03-27 |
| Vital™ Spinal Fixation System (K240539) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-03-15 |
| 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM (K232607) | Solco Biomedical Copany India Private Limited | 2024-02-27 |
| VADER® Pedicle System (K232628) | Icotec AG | 2024-02-26 |
| M.U.S.T. Pedicle Screw System - Extension (K234048) | Medacta International S.A. | 2024-02-13 |
| INNOVERSE Spinal System (K233960) | Innosys Co., Ltd. | 2024-02-06 |
| CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (K233944) | CarboFix Orthopedics , Ltd. | 2024-01-10 |
| POWEReam 1/4 Drive (K233300) | Stryker Instruments | 2023-12-26 |
| TriALTIS™ Spine System (K233684) | Medos International SARL | 2023-12-12 |
| ARx MIS Spinal Screw System (K233455) | Life Spine, Inc. | 2023-12-12 |
| Mini-OSTEO Pedicle Fixation System (K231443) | Osteomed Indústria E Comércio DE Implantes Ltda | 2023-11-21 |
| ProMIS Extension Rod System (K232719) | Premia Spine, Ltd. | 2023-11-21 |
| MASADA Modular Spinal Fixation System (K231694) | Astura Medical | 2023-11-16 |
| PressON Spinal Fixation System (K233234) | Nexus Spine, LLC | 2023-10-26 |
| ANAX™ 5.5 Spinal System (K231737) | Innosys Co., Ltd. | 2023-10-26 |
| PERLA® TL Posterior Thoraco-lumbar Fixation System (K231069) | Spineart SA | 2023-10-25 |
| Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System (K232586) | K&J Consulting Corp. | 2023-10-24 |
| Ripley Spinal Screw System by SAGICO (K232561) | Sagico VA USA, LLC | 2023-10-23 |
| VyLink™ Spinal Screw System (K231744) | Vy Spine, LLC | 2023-10-13 |
| Vital™ Spinal Fixation System (K230116) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-10-11 |
| Zeus Spinal System (K230961) | Shanghai Sanyou Medical Co, Ltd. | 2023-10-10 |
| VEOS Spinal Fixation System (K231658) | Spineway | 2023-10-10 |
| CarboClear® Pedicle Screw System (K232341) | CarboFix Orthopedics , Ltd. | 2023-10-10 |