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 2 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233234 | PressON Spinal Fixation System | Nexus Spine, LLC | 2023-10-26 | Special | PDF ↗ |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2023-10-25 | Traditional | PDF ↗ |
| K232586 | Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System | K&J Consulting Corp. | 2023-10-24 | Traditional | PDF ↗ |
| K232561 | Ripley Spinal Screw System by SAGICO | Sagico VA USA, LLC | 2023-10-23 | Traditional | PDF ↗ |
| K231744 | VyLink Spinal Screw System | Vy Spine, LLC | 2023-10-13 | Traditional | PDF ↗ |
| K230116 | Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-10-11 | Traditional | PDF ↗ |
| K230961 | Zeus Spinal System | Shanghai Sanyou Medical Co, Ltd. | 2023-10-10 | Special | PDF ↗ |
| K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. | 2023-10-10 | Traditional | PDF ↗ |
| K231658 | VEOS Spinal Fixation System | Spineway | 2023-10-10 | Traditional | PDF ↗ |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2023-09-29 | Special | PDF ↗ |
| K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023-09-27 | Traditional | PDF ↗ |
| K231479 | TriALTIS Spine System | Medos International SARL | 2023-09-22 | Traditional | PDF ↗ |
| K230974 | NIDO Pedicle Screw System | Kalitec Medical | 2023-09-15 | Traditional | PDF ↗ |
| K232218 | Zenius Spinal System | Medyssey USA, Inc. | 2023-08-24 | Special | PDF ↗ |
| K231811 | Zavation Connector System | Zavation Medical Products, LLC | 2023-08-22 | Traditional | PDF ↗ |
| K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | Medtronic Sofamor Danek USA, Inc. | 2023-08-16 | Special | PDF ↗ |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2023-08-14 | Special | PDF ↗ |
| K231098 | LineSider® Spinal System | Integrity Implants, Inc. | 2023-08-07 | Traditional | PDF ↗ |
| K231931 | Adena-Zina Spinal System | Shanghai Sanyou Medical Co, Ltd. | 2023-07-28 | Special | PDF ↗ |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw System | Nexxt Spine, LLC | 2023-07-20 | Special | PDF ↗ |
| K231844 | ProMIS Fixation System | Premia Spine, Ltd. | 2023-07-07 | Special | PDF ↗ |
| K223806 | VERTICALE® Triangular Fixation System | Silony Medical GmbH | 2023-07-06 | Traditional | PDF ↗ |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | CarboFix Orthopedics , Ltd. | 2023-07-03 | Traditional | PDF ↗ |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | L&K BIOMED Co., Ltd. | 2023-06-27 | Special | PDF ↗ |
| K230762 | EDEN Spinal Fixation MIS System | Jmt Co., Ltd. | 2023-06-15 | Special | PDF ↗ |
| K222684 | 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 | Stryker Spine | 2023-06-08 | Traditional | PDF ↗ |
| K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | 2023-05-26 | Traditional | PDF ↗ |
| K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023-05-25 | Traditional | PDF ↗ |
| K223529 | PressON Spinal Fixation System | Nexus Spine, LLC | 2023-05-02 | Traditional | PDF ↗ |
| K212220 | ArtFX Spinal Fixation System | Artfx Medical, LLC | 2023-04-20 | Traditional | PDF ↗ |
| K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | 2023-04-19 | Special | PDF ↗ |
| K230482 | Swedge Pedicle Screw Fixation System | Spinal Resources, Inc. | 2023-03-23 | Special | PDF ↗ |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | OrthoPediatrics Corp. | 2023-03-23 | Special | PDF ↗ |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2023-02-28 | Special | PDF ↗ |
| K230063 | G Surgical Marksman Spinal Deformity System | G Surgical, LLC | 2023-02-09 | Special | PDF ↗ |
| K223494 | CD Horizon Spinal System | Medtronic | 2023-01-23 | Traditional | PDF ↗ |
| K223181 | NuVasive Reline System | Nu Vasive, Incorporated | 2023-01-11 | Traditional | PDF ↗ |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | L&K BIOMED Co., Ltd. | 2022-12-23 | Special | PDF ↗ |
| K223273 | ASTRA Spine System | Spinecraft, LLC | 2022-12-22 | Traditional | PDF ↗ |
| K222614 | Zavation Spinal System | Zavation Medical Products, LLC | 2022-12-05 | Traditional | PDF ↗ |
| K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022-12-01 | Traditional | PDF ↗ |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | Ulrich Medical USA | 2022-11-28 | Special | PDF ↗ |
| K212700 | Dyflex-II | Taeyeon Medical Co., Ltd. | 2022-11-15 | Traditional | PDF ↗ |
| K222031 | Spinal Inner Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2022-10-28 | Traditional | PDF ↗ |
| K222415 | Rexious Spinal Fixation System | Dio Medical Corporation | 2022-10-25 | Traditional | PDF ↗ |
| K222473 | EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods | Medos-International Sarl | 2022-10-13 | Traditional | PDF ↗ |
| K221646 | 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 | Medtronic Sofamor Danek USA, Inc. | 2022-10-04 | Traditional | PDF ↗ |
| K220297 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | 2022-09-16 | Traditional | PDF ↗ |
| K211027 | Altus Spine Pedicle Screw System | Altus Partners, LLC | 2022-09-16 | Traditional | PDF ↗ |
| K222110 | Mariner RDX System | SeaSpine Orthopedics Corporation | 2022-09-07 | Traditional | PDF ↗ |
| K221745 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co, Ltd. | 2022-08-31 | Special | PDF ↗ |
| K222362 | Salvo® Spine System | Spine Wave, Inc. | 2022-08-29 | Special | PDF ↗ |
| K221403 | Cortera Spinal Fixation System | Surgalign Spine Technologies | 2022-08-19 | Traditional | PDF ↗ |
| K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022-08-09 | Traditional | PDF ↗ |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener System | OsteoCentric Technologies | 2022-07-28 | Traditional | PDF ↗ |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw System | Nexxt Spine, LLC | 2022-07-28 | Special | PDF ↗ |
| K220486 | Kentrospine PSS Pedicle Screw System | Rivarp Medical Private Limited | 2022-07-22 | Traditional | PDF ↗ |
| K201788 | EDEN Spinal Fixation System | Jmt Co., Ltd. | 2022-06-23 | Traditional | PDF ↗ |
| K211981 | KHEIRON® Spinal Fixation System | S.M.A.I.O | 2022-06-09 | Traditional | PDF ↗ |
| K203233 | 4CIS Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2022-06-01 | Special | PDF ↗ |
| K221244 | CD Horizon Spinal System | Medtronic | 2022-05-25 | Special | PDF ↗ |
| K220285 | PINE Pedicle Screw System | Tdm Co., Ltd. | 2022-05-19 | Traditional | PDF ↗ |
| K220341 | ARx Modular Spinal System | Life Spine, Inc. | 2022-05-02 | Traditional | PDF ↗ |
| K220724 | CD Horizon Spinal System and PASS LP Spinal System | Medicrea International | 2022-04-08 | Special | PDF ↗ |
| K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022-04-04 | Traditional | PDF ↗ |
| K220025 | ARx® Spinal System | Life Spine, Inc. | 2022-03-31 | Traditional | PDF ↗ |
| K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | Medos International SARL | 2022-03-08 | Special | PDF ↗ |
| K213750 | VyLink Spinal Screw System | Vy Spine, LLC | 2022-02-28 | Traditional | PDF ↗ |
| K212627 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | 2022-02-18 | Special | PDF ↗ |
| K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | 2022-01-21 | Traditional | PDF ↗ |
| K213281 | PASS LP Spinal System, CD Horizon Spinal System | Medicrea International SA | 2022-01-05 | Traditional | PDF ↗ |
| K213460 | Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2021-12-10 | Traditional | PDF ↗ |
| K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021-09-21 | Special | PDF ↗ |
| K203607 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | 2021-08-20 | Traditional | PDF ↗ |
| K212185 | Golden Isles Pedicle Screw System | Intelivation, LLC | 2021-08-19 | Traditional | PDF ↗ |
| K212066 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2021-08-16 | Traditional | PDF ↗ |
| K211414 | KHEIRON Spinal Fixation System | S.M.A.I.O | 2021-08-10 | Traditional | PDF ↗ |
| K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021-07-21 | Special | PDF ↗ |
| K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2021-07-19 | Traditional | PDF ↗ |
| K203023 | Pisces Spinal System | Ortho Development Corporation | 2021-07-14 | Traditional | PDF ↗ |
| K211113 | Zavation Spinal System | Zavation Medical Products, LLC | 2021-07-12 | Traditional | PDF ↗ |
| K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021-06-23 | Special | PDF ↗ |
| K201737 | Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co, Ltd. | 2021-06-21 | Traditional | PDF ↗ |
| K211323 | ASTRA Spine System | Spinecraft, LLC | 2021-06-03 | Special | PDF ↗ |
| K210306 | GII Spinal Fixation System | Coligne AG | 2021-05-19 | Special | PDF ↗ |
| K210816 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | 2021-05-18 | Special | PDF ↗ |
| K210874 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2021-05-13 | Special | PDF ↗ |
| K210637 | CD Horizon Spinal System | Medtronic | 2021-04-30 | Traditional | PDF ↗ |
| K210549 | ARx Spinal System | Life Spine, Inc. | 2021-04-22 | Traditional | PDF ↗ |
| K210427 | M.U.S.T. Midline Cortical (MC) Screw System | Medacta International S.A. | 2021-04-20 | Traditional | PDF ↗ |
| K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | 2021-04-19 | Traditional | PDF ↗ |
| K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021-04-15 | Traditional | PDF ↗ |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | CarboFix Orthopedics , Ltd. | 2021-04-06 | Special | PDF ↗ |
| K201457 | Auxein Brand Vertaux 5.5 mm Pedicle Screw System | Auxein Medical Private Limited/71164 | 2021-04-06 | Traditional | PDF ↗ |
| K210275 | Polaris Spinal System | Zimmer Biomet Spine, Inc. | 2021-04-02 | Special | PDF ↗ |
| K201420 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2021-03-05 | Traditional | PDF ↗ |
| K202498 | 4CIS SARA Spine System, 4CIS VERTU Spine System | Solco Biomedical Company India Private Limited | 2021-02-18 | Traditional | PDF ↗ |
| K203507 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2021-01-28 | Traditional | PDF ↗ |
| K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab Implants | Medacta International S.A. | 2021-01-26 | Traditional | PDF ↗ |
| K200922 | Altus Spine HA Pedicle Screw System | Altus Partners, LLC | 2021-01-26 | Special | PDF ↗ |
Product code NKB · Class II · Orthopedic. Data: openFDA.