Lateral Plate System
FDA 510(k) K190016 · Corelink, LLC
510(k) numberK190016
Submission
- Device name
- Lateral Plate System
- Applicant
- Corelink, LLC
St. Louis, MO, US - Received
- January 3, 2019
- Decision date
- June 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…MAX · Traditional | 12/08/2023SE |
| K231494 | CoreLink Robotic Navigation InstrumentsOLO · Traditional | 10/27/2023SE |
| K232116 | CoreLink Navigation InstrumentsOLO · Special | 08/16/2023SE |
| K230329 | F3D Interbody SystemODP · Traditional | 06/06/2023SE |
| K230880 | CoreLink Navigation InstrumentsOLO · Special | 05/02/2023SE |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant SystemOUR · Traditional | 03/21/2023SE |
| K221776 | NextGen Pedicle Screw SystemNKB · Traditional | 08/09/2022SE |
| K220973 | CoreLink Navigation InstrumentsOLO · Traditional | 06/01/2022SE |
| K211417 | F3D-C2 Cervical Stand-Alone SystemOVE · Traditional | 02/04/2022SE |
| K214059 | CoreLink Navigation InstrumentsOLO · Special | 01/19/2022SE |
Questions and answers
When was Lateral Plate System cleared by the FDA?
Lateral Plate System (K190016) received a 510(k) decision of Substantially Equivalent on June 12, 2019, 160 days after the submission was received.
What is the product code of K190016?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.