FORTICO Anterior Cervical Fixation System
FDA 510(k) K191584 · Camber Spine Technologies, LLC
510(k) numberK191584
Submission
- Device name
- FORTICO Anterior Cervical Fixation System
- Applicant
- Camber Spine Technologies, LLC
King Of Prussia, PA, US - Received
- June 14, 2019
- Decision date
- October 22, 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 |
|---|---|---|
| K234077 | SPIRA® Anterior Lumbar SpacersMAX · Traditional | 07/12/2024SE |
| K232256 | Alcantara Thoracolumbar Plate SystemKWQ · Traditional | 04/16/2024SE |
| K233972 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 02/27/2024SE |
| K230942 | SPIRA® Posterior Lumbar SpacersMAX · Traditional | 07/11/2023SE |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVD · Traditional | 03/30/2023SE |
| K223837 | SPIRA®-C Integrated Fixation SystemOVE · Traditional | 03/22/2023SE |
| K203503 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 09/02/2022SE |
| K220038 | Camber Spine Navigation SystemOLO · Traditional | 04/29/2022SE |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAX · Traditional | 06/15/2021SE |
| K193153 | SPIRA-C Integrated Fixation SystemOVE · Traditional | 04/24/2020SE |
Questions and answers
When was FORTICO Anterior Cervical Fixation System cleared by the FDA?
FORTICO Anterior Cervical Fixation System (K191584) received a 510(k) decision of Substantially Equivalent on October 22, 2019, 130 days after the submission was received.
What is the product code of K191584?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.