Cure OPEL-C Plate System
FDA 510(k) K181543 · Meditech Spine, LLC
510(k) numberK181543
Submission
- Device name
- Cure OPEL-C Plate System
- Applicant
- Meditech Spine, LLC
Atlanta, GA, US - Received
- June 12, 2018
- Decision date
- August 31, 2018
- 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 |
|---|---|---|
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) SystemKWQ · Special | 03/18/2021SE |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…ODP · Special | 09/11/2020SE |
| K201136 | Cure Lumbar Plate SystemKWQ · Special | 05/12/2020SE |
| K180090 | Cure Lumbar Plate SystemKWQ · Special | 04/23/2018SE |
| K171538 | Cure Lumbar Plate SystemKWQ · Traditional | 06/16/2017SE |
| K170395 | Talos® Lumbar (HA) PEEK IBF DevicesMAX · Traditional | 06/02/2017SE |
| K160604 | Cure Anterior Cervical Plate (ACP) SystemKWQ · Traditional | 07/01/2016SE |
| K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…ODP · Traditional | 10/14/2015SE |
| K142345 | Talos-C(HA) Cervical Intervertebral Body Fusion DevicesODP · Traditional | 02/22/2015SE |
Questions and answers
When was Cure OPEL-C Plate System cleared by the FDA?
Cure OPEL-C Plate System (K181543) received a 510(k) decision of Substantially Equivalent on August 31, 2018, 80 days after the submission was received.
What is the product code of K181543?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.