icotec Anterior Cervical Plate System
FDA 510(k) K201587 · Icotec AG
510(k) numberK201587
Submission
- Device name
- icotec Anterior Cervical Plate System
- Applicant
- Icotec AG
Altstaetten, CH - Received
- June 11, 2020
- Decision date
- October 15, 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 |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | 11/12/2025SE |
| K242900 | VADER® Pedicle System and VADER®one Pedicle SystemNKB · Traditional | 02/27/2025SE |
| K233215 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 05/17/2024SE |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…MAX · Traditional | 04/05/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | 04/04/2024SE |
| K232628 | VADER® Pedicle SystemNKB · Traditional | 02/26/2024SE |
| K230861 | VADER® Pedicle System Navigated InstrumentsOLO · Traditional | 06/27/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | 01/09/2023SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | 10/13/2020SE |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | 05/29/2020SE |
Questions and answers
When was icotec Anterior Cervical Plate System cleared by the FDA?
icotec Anterior Cervical Plate System (K201587) received a 510(k) decision of Substantially Equivalent on October 15, 2020, 126 days after the submission was received.
What is the product code of K201587?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.