Artus cervical plate system
FDA 510(k) K202227 · Ulrich GmbH & Co. KG
510(k) numberK202227
Submission
- Device name
- Artus cervical plate system
- Applicant
- Ulrich GmbH & Co. KG
Ulm, DE - Received
- August 7, 2020
- Decision date
- September 14, 2020
- 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 |
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| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | 04/19/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | 08/06/2021SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | 07/02/2020SE |
| K192117 | Small VBRMQP · Traditional | 11/01/2019SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | 11/09/2017SE |
| K161032 | neon3 universal OCT spinal stabilizationNKG · Traditional | 12/22/2016SE |
| K161723 | ulrich Transfer SetPQH · Traditional | 12/21/2016SE |
Questions and answers
When was Artus cervical plate system cleared by the FDA?
Artus cervical plate system (K202227) received a 510(k) decision of Substantially Equivalent on September 14, 2020, 38 days after the submission was received.
What is the product code of K202227?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.