CervAlign Anterior Cervical Plate System
FDA 510(k) K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
510(k) numberK183060
Submission
- Device name
- CervAlign Anterior Cervical Plate System
- Applicant
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Marquette, MI, US - Received
- November 2, 2018
- Decision date
- January 17, 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 |
|---|---|---|
| K201497 | EVOS Cabling SystemJDQ · Traditional | 10/28/2020SE |
| K200513 | DAC Dynamic Active Compression PlateHRS · Traditional | 07/22/2020SE |
| K200095 | Streamline Navigated InstrumentsOLO · Traditional | 06/26/2020SE |
| K193468 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 03/12/2020SE |
| K192800 | Streamline TL Spinal Fixation SystemNKB · Traditional | 01/14/2020SE |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyMAX · Traditional | 12/20/2019SE |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs:…MAX · Traditional | 07/05/2019SE |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic SystemNKG · Traditional | 08/18/2017SE |
| K170830 | Unison-C Anterior Cervical Fixation SystemOVE · Traditional | 06/28/2017SE |
| K161876 | Tritium® Sternal Cable Plate SystemJDQ · Special | 09/09/2016SE |
Questions and answers
When was CervAlign Anterior Cervical Plate System cleared by the FDA?
CervAlign Anterior Cervical Plate System (K183060) received a 510(k) decision of Substantially Equivalent on January 17, 2019, 76 days after the submission was received.
What is the product code of K183060?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.