Xenco Medical Multilevel CerviKit
FDA 510(k) K213456 · Xenco Medical, LLC
510(k) numberK213456
Submission
- Device name
- Xenco Medical Multilevel CerviKit
- Applicant
- Xenco Medical, LLC
San Diego, CA, US - Received
- October 26, 2021
- Decision date
- December 21, 2021
- 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 |
|---|---|---|
| K243673 | Xenco Medical CancelleX Cervical Interbody SystemODP · Traditional | 01/29/2025SE |
| K223059 | Xenco Medical InterAlign Cervical Interbody SystemOVE · Traditional | 06/07/2023SE |
| K191074 | Sorrento Bone Graft SubstituteMQV · Traditional | 09/27/2019SE |
| K190364 | CancelleX Porous Titanium Lumbar Interbody DeviceMAX · Traditional | 04/18/2019SE |
| K173933 | Sorrento Bioglass Bone Graft SubstituteMQV · Traditional | 09/13/2018SE |
| K180373 | CancelleX Porous Titanium Lumbar Interbody DeviceMAX · Traditional | 08/24/2018SE |
| K170611 | SETx Pedicle Screw SystemNKB · Traditional | 05/25/2017SE |
| K160313 | Xenco Medical Cervical Interbody SystemOVE · Traditional | 10/21/2016SE |
| K161478 | Xenco Medical Posterior Cervical SystemNKG · Traditional | 09/06/2016SE |
| K160986 | Xenco Medical Pedicle Screw SystemNKB · Special | 05/04/2016SE |
Questions and answers
When was Xenco Medical Multilevel CerviKit cleared by the FDA?
Xenco Medical Multilevel CerviKit (K213456) received a 510(k) decision of Substantially Equivalent on December 21, 2021, 56 days after the submission was received.
What is the product code of K213456?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.