Cervical Plate
FDA 510(k) K190565 · Eisertech, LLC
510(k) numberK190565
Submission
- Device name
- Cervical Plate
- Applicant
- Eisertech, LLC
San Diego, CA, US - Received
- March 5, 2019
- Decision date
- May 31, 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 |
|---|---|---|
| K192768 | Temporary Fixation PinsJDW · Traditional | 12/26/2019SE |
| K140348 | Interbody CageMAX · Traditional | 04/23/2015SE |
| K142576 | Spinal SystemNKB · Traditional | 02/26/2015SE |
| K122444 | Cervical CageODP · Special | 08/30/2012SE |
| K113170 | Cervical PlateKWQ · Traditional | 04/06/2012SE |
| K113478 | Plif CageMAX · Abbreviated | 03/05/2012SE |
| K110915 | Cervical CageODP · Abbreviated | 07/22/2011SE |
Questions and answers
When was Cervical Plate cleared by the FDA?
Cervical Plate (K190565) received a 510(k) decision of Substantially Equivalent on May 31, 2019, 87 days after the submission was received.
What is the product code of K190565?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.