4CIS® Pinehurst Anterior Cervical Plate system
FDA 510(k) K182489 · Solco Biomedical Co., Ltd.
510(k) numberK182489
Submission
- Device name
- 4CIS® Pinehurst Anterior Cervical Plate system
- Applicant
- Solco Biomedical Co., Ltd.
Pyeongtaek, KR - Received
- September 11, 2018
- Decision date
- January 16, 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
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K231655 | 4CIS® Chiron Spinal Fixation SystemNKB · Special | 11/26/2024SE |
| K203233 | 4CIS Chiron Spinal Fixation SystemNKB · Special | 06/01/2022SE |
| K192044 | 4CIS Marlin PEEK ACIF CageODP · Traditional | 12/19/2019SE |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…MAX · Traditional | 09/18/2019SE |
| K190471 | 4CIS® Chiron Spinal Fixation SystemNKB · Traditional | 07/24/2019SE |
| K162402 | 4CIS® Marlin ACIF Cage SystemODP · Traditional | 02/16/2017SE |
| K121615 | 4CIS Vane Spine SystemMNI · Special | 08/15/2012SE |
| K102458 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemMNH · Special | 06/13/2011SE |
| K101818 | 4CIS Vane Spine SystemMNH · Traditional | 02/11/2011SE |
| K092162 | 4CIS PEEK, Plif and Tlif Cage SystemMAX · Traditional | 01/06/2010SE |
Questions and answers
When was 4CIS® Pinehurst Anterior Cervical Plate system cleared by the FDA?
4CIS® Pinehurst Anterior Cervical Plate system (K182489) received a 510(k) decision of Substantially Equivalent on January 16, 2019, 127 days after the submission was received.
What is the product code of K182489?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.