Skyway Anterior Cervical Plate System
FDA 510(k) K243015 · Kyocera Medical Technologies, Inc.
510(k) numberK243015
Submission
- Device name
- Skyway Anterior Cervical Plate System
- Applicant
- Kyocera Medical Technologies, Inc.
Redlands, CA, US - Received
- September 27, 2024
- Decision date
- November 5, 2024
- 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 |
|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | 07/15/2026SE |
| K242928 | Tesera-k SC SystemOVE · Traditional | 04/10/2025SE |
| K242045 | Initia T3 Acetabular Hemispherical Shell SystemLPH · Traditional | 04/10/2025SE |
| K242771 | Tesera-k PL System and Tesera-k XL SystemMAX · Traditional | 03/20/2025SE |
| K243295 | Initia Knee SystemJWH · Traditional | 01/13/2025SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | 04/04/2024SE |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Special | 04/21/2023SE |
| K223105 | Tesera-K SC SystemOVE · Traditional | 12/22/2022SE |
| K212980 | Tesera-k ALIF SystemOVD · Traditional | 01/07/2022SE |
| K212070 | KMTI S141 Lumbar Interbody Fusion SystemMAX · Special | 08/30/2021SE |
Questions and answers
When was Skyway Anterior Cervical Plate System cleared by the FDA?
Skyway Anterior Cervical Plate System (K243015) received a 510(k) decision of Substantially Equivalent on November 5, 2024, 39 days after the submission was received.
What is the product code of K243015?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.