| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K232650) | S.M.A.I.O | 2023-09-29 |
| Invictus® Spinal Fixation System (K232275) | Alphatec Spine, Inc. | 2023-09-27 |
| TriALTIS Spine System (K231479) | Medos International SARL | 2023-09-22 |
| NIDO™ Pedicle Screw System (K230974) | Kalitec Medical | 2023-09-15 |
| Zenius™ Spinal System (K232218) | Medyssey USA, Inc. | 2023-08-24 |
| Zavation Connector System (K231811) | Zavation Medical Products, LLC | 2023-08-22 |
| CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) (K232141) | Medtronic Sofamor Danek USA, Inc. | 2023-08-16 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System (K232311) | L&K BIOMED Co., Ltd. | 2023-08-14 |
| LineSider® Spinal System (K231098) | Integrity Implants, Inc. | 2023-08-07 |
| Adena-Zina Spinal System (K231931) | Shanghai Sanyou Medical Co, Ltd. | 2023-07-28 |
| INERTIA® CONNEXX™ Modular Pedicle Screw System (K231799) | Nexxt Spine, LLC | 2023-07-20 |
| ProMIS™ Fixation System (K231844) | Premia Spine, Ltd. | 2023-07-07 |
| VERTICALE® Triangular Fixation System (K223806) | Silony Medical GmbH | 2023-07-06 |
| CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement (K231280) | CarboFix Orthopedics , Ltd. | 2023-07-03 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K231636) | L&K BIOMED Co., Ltd. | 2023-06-27 |
| EDEN Spinal Fixation MIS System (K230762) | Jmt Co., Ltd. | 2023-06-15 |
| XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (K222684) | Stryker Spine | 2023-06-08 |
| Dark Star Deformity Pedicle Screw System (K223096) | Republic Spine, LLC | 2023-05-26 |
| Advanced LumFix Spinal Fixation System (K222229) | CG Bio Co., Ltd. | 2023-05-25 |
| PressON Spinal Fixation System (K223529) | Nexus Spine, LLC | 2023-05-02 |
| ArtFX Spinal Fixation System (K212220) | Artfx Medical, LLC | 2023-04-20 |
| Altus Spine Monaco Pedicle Screw System (K230766) | Altus Spine | 2023-04-19 |
| Swedge™ Pedicle Screw Fixation System (K230482) | Spinal Resources, Inc. | 2023-03-23 |
| RESPONSE 5.5/6.0 Cannulated Screw System (K222105) | OrthoPediatrics Corp. | 2023-03-23 |
| LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (K230245) | L&K BIOMED Co., Ltd. | 2023-02-28 |
| G Surgical Marksman Spinal Deformity System (K230063) | G Surgical, LLC | 2023-02-09 |
| CD Horizon Spinal System (K223494) | Medtronic | 2023-01-23 |
| NuVasive Reline System (K223181) | Nu Vasive, Incorporated | 2023-01-11 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K223565) | L&K BIOMED Co., Ltd. | 2022-12-23 |
| ASTRA Spine System (K223273) | Spinecraft, LLC | 2022-12-22 |
| Zavation Spinal System (K222614) | Zavation Medical Products, LLC | 2022-12-05 |
| Mercury® II Spinal System (K222516) | Spinal Elements, Inc. | 2022-12-01 |
| Momentum® MIS Posterior Spinal Fixation System (K223274) | Ulrich Medical USA | 2022-11-28 |
| Dyflex-II (K212700) | Taeyeon Medical Co., Ltd. | 2022-11-15 |
| Spinal Inner Fixation System (K222031) | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2022-10-28 |
| Rexious Spinal Fixation System (K222415) | Dio Medical Corporation | 2022-10-25 |
| EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods (K222473) | Medos-International Sarl | 2022-10-13 |
| CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (K221646) | Medtronic Sofamor Danek USA, Inc. | 2022-10-04 |
| Altus Spine Pedicle Screw System (K211027) | Altus Partners, LLC | 2022-09-16 |
| True Tulip, True M.I.S. (K220297) | Innovative Surgical Designs, Inc. | 2022-09-16 |
| Mariner RDX System (K222110) | SeaSpine Orthopedics Corporation | 2022-09-07 |
| Sterile Posterior Spinal Fixation System (K221745) | Shanghai Reach Medical Instrument Co, Ltd. | 2022-08-31 |
| Salvo® Spine System (K222362) | Spine Wave, Inc. | 2022-08-29 |
| Cortera Spinal Fixation System (K221403) | Surgalign Spine Technologies | 2022-08-19 |
| NextGen Pedicle Screw System (K221776) | Corelink, LLC | 2022-08-09 |
| INERTIA CONNEXX Modular Pedicle Screw System (K221905) | Nexxt Spine, LLC | 2022-07-28 |
| OsteoCentric Spine MIS Pedicle Fastener System (K221332) | OsteoCentric Technologies | 2022-07-28 |
| Kentrospine PSS Pedicle Screw System (K220486) | Rivarp Medical Private Limited | 2022-07-22 |
| EDEN Spinal Fixation System (K201788) | Jmt Co., Ltd. | 2022-06-23 |
| KHEIRON® Spinal Fixation System (K211981) | S.M.A.I.O | 2022-06-09 |
| 4CIS Chiron Spinal Fixation System (K203233) | Solco Biomedical Co., Ltd. | 2022-06-01 |
| CD Horizon™ Spinal System (K221244) | Medtronic | 2022-05-25 |
| PINE Pedicle Screw System (K220285) | Tdm Co., Ltd. | 2022-05-19 |
| ARx Modular Spinal System (K220341) | Life Spine, Inc. | 2022-05-02 |
| CD Horizon™ Spinal System and PASS LP™ Spinal System (K220724) | Medicrea International | 2022-04-08 |
| Invictus® Spinal Fixation System (K214006) | Alphatec Spine, Inc. | 2022-04-04 |
| ARx® Spinal System (K220025) | Life Spine, Inc. | 2022-03-31 |
| EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) (K220374) | Medos International SARL | 2022-03-08 |
| VyLink™ Spinal Screw System (K213750) | Vy Spine, LLC | 2022-02-28 |
| True Tulip, True M.I.S. (K212627) | Innovative Surgical Designs, Inc. | 2022-02-18 |
| PERLA® TL Posterior Osteosynthesis System (K213470) | Spineart | 2022-01-21 |
| PASS LP™ Spinal System, CD Horizon™ Spinal System (K213281) | Medicrea International SA | 2022-01-05 |
| Invictus Spinal Fixation System (K213460) | Alphatec Spine, Inc. | 2021-12-10 |
| Mariner Pedicle Screw System (K212692) | SeaSpine Orthopedics Corporation | 2021-09-21 |
| MOSS VRS Spinal System (K203607) | Biedermann Motech GmbH & Co. KG | 2021-08-20 |
| Golden Isles Pedicle Screw System (K212185) | Intelivation, LLC | 2021-08-19 |
| Adena-Zina System (K212066) | Shanghai Sanyou Medical Co, Ltd. | 2021-08-16 |
| KHEIRON Spinal Fixation System (K211414) | S.M.A.I.O | 2021-08-10 |
| CD Horizon Spinal System (K211958) | Medtronic Sofamor Danek USA, Inc. | 2021-07-21 |
| ENNOVATE Spinal System (K210963) | Aesculap Implant Systems, LLC | 2021-07-19 |
| Pisces Spinal System (K203023) | Ortho Development Corporation | 2021-07-14 |
| Zavation Spinal System (K211113) | Zavation Medical Products, LLC | 2021-07-12 |
| Mariner Deformity System (K211606) | SeaSpine Orthopedics Corporation | 2021-06-23 |
| Posterior Spinal Fixation System (K201737) | Shanghai Reach Medical Instrument Co, Ltd. | 2021-06-21 |
| ASTRA Spine System (K211323) | Spinecraft, LLC | 2021-06-03 |
| GII Spinal Fixation System (K210306) | Coligne AG | 2021-05-19 |
| True Tulip, True M.I.S. (K210816) | Innovative Surgical Designs, Inc. | 2021-05-18 |
| Reliance Spinal Screw System (K210874) | Reliance Medical Systems, LLC | 2021-05-13 |
| CD Horizon™ Spinal System (K210637) | Medtronic | 2021-04-30 |
| ARx Spinal System (K210549) | Life Spine, Inc. | 2021-04-22 |
| M.U.S.T. Midline Cortical (MC) Screw System (K210427) | Medacta International S.A. | 2021-04-20 |
| Goblin and Goblin LS Pedicle Screw Systems (K210420) | Medynus, Inc. | 2021-04-19 |
| CoreLink Midline Fixation System (K210539) | Corelink, LLC | 2021-04-15 |
| Auxein Brand Vertaux 5.5 mm Pedicle Screw System (K201457) | Auxein Medical Private Limited/71164 | 2021-04-06 |
| CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments (K210716) | CarboFix Orthopedics , Ltd. | 2021-04-06 |
| Polaris Spinal System (K210275) | Zimmer Biomet Spine, Inc. | 2021-04-02 |
| Republic Spine Dark Star Spinal System (K201420) | Republic Spine, LLC | 2021-03-05 |
| 4CIS SARA Spine System, 4CIS VERTU Spine System (K202498) | Solco Biomedical Company India Private Limited | 2021-02-18 |
| Vitality® Spinal Fixation System (K203507) | Zimmer Biomet Spine, Inc. | 2021-01-28 |
| Altus Spine HA Pedicle Screw System (K200922) | Altus Partners, LLC | 2021-01-26 |
| M.U.S.T. Pedicle Screw Extension and Long Tab Implants (K203482) | Medacta International S.A. | 2021-01-26 |
| CREO Stabilization System, Navigation Instruments, ExcelsiusGPS (K203153) | Globus Medical, Inc. | 2021-01-19 |
| PERLA® TL posterior osteosynthesis system (K203506) | Spineart | 2021-01-15 |
| GetSet Surgical GoPLF! Posterior Lateral Fusion System (K202505) | Getset Surgical, SA | 2021-01-11 |
| Nano FortiFix® System (K203452) | Nanovis, LLC | 2020-12-22 |
| ARx Illiac Spinal Screw System (K203163) | Life Spine, Inc. | 2020-12-17 |
| PERLA TL Posterior Osteosynthesis System (K203222) | Spineart | 2020-12-17 |
| LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System (K200789) | L&K BIOMED Co., Ltd. | 2020-12-04 |
| LineSider™ Spinal System (K203367) | Integrity Implants, Inc. | 2020-12-03 |
| CarboClear X Pedicle Screw System (K203317) | CarboFix Orthopedics , Ltd. | 2020-11-25 |