Product code KWQ
- Device name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3060
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262149 | corra® cervical plating system | Carlsmed, Inc. | 2026-09-24 |
| K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | 2026-07-16 |
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026-05-06 |
| K260570 | corra™ cervical plating system | Carlsmed, Inc. | 2026-04-22 |
| K260697 | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | 2026-03-27 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026-03-04 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026-03-03 |
| K254182 | Aster | Osteonic Co., Ltd. | 2026-02-26 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026-02-12 |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025-12-22 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025-08-28 |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025-07-11 |
| K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025-05-23 |
| K250602 | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | 2025-05-20 |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 |
| K243369 | Cervical Plating System | Life Spine, Inc. | 2024-12-11 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal Syste... | Stryker Spine | 2024-11-07 |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024-11-05 |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024-07-24 |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | 2024-05-24 |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | 2024-05-17 |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | 2024-05-17 |
| K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | 2024-05-17 |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-04-17 |
| K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024-04-16 |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | 2024-04-08 |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine | 2024-03-22 |
| K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | 2024-03-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810017916191 | SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°) | ELEVATION SPINE, INC. | 2026-10-27 |
| 00810017913961 | Saber-C Body (PT), 14x17x7 9 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914463 | Saber-C Body (PT), 14x15x10 12 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914456 | Saber-C Body (PT), 14x15x9 12 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914449 | Saber-C Body (PT), 14x15x8 12 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914432 | Saber-C Body (PT), 14x15x7 12 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914425 | Saber-C Body (PT), 14x15x6 12 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914050 | Saber-C Body (PT), 15x18x10 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914043 | Saber-C Body (PT), 15x18x9 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914036 | Saber-C Body (PT), 15x18x8 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914029 | Saber-C Body (PT), 15x18x7 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914012 | Saber-C Body (PT), 15x18x6 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017914005 | Saber-C Body (PT), 15x18x5 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913992 | Saber-C Body (PT), 14x17x10 9 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913985 | Saber-C Body (PT), 14x17x9 9 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913978 | Saber-C Body (PT), 14x17x8 9 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913954 | Saber-C Body (PT), 14x17x6 9 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913947 | Saber-C Body (PT), 14x17x5 9 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913930 | Saber-C Body (PT), 14x17x10 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913824 | Saber-C Body (PT), 14x15x5 9 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913817 | Saber-C Body (PT), 14x15x10 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913800 | Saber-C Body (PT), 14x15x9 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913794 | Saber-C Body (PT), 14x15x8 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913787 | Saber-C Body (PT), 14x15x7 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913770 | Saber-C Body (PT), 14x15x6 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| 00810017913763 | Saber-C Body (PT), 14x15x5 6 deg. | ELEVATION SPINE, INC. | 2026-10-26 |
| M999CTL418930 | GPS Anterior Cervical Plate System | G SURGICAL LLC | 2016-09-14 |
| M999CSS018030 | GPS Anterior Cervical Plate System | G SURGICAL LLC | 2016-09-07 |
| M999CSS040120 | GPS Anterior Cervical Plate System | G SURGICAL LLC | 2016-09-07 |
| 00643169118577 | CD HORIZON® Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2015-06-17 |