Transept Cervical Plate System
FDA 510(k) K200927 · Neurostructures, Inc.
510(k) numberK200927
Submission
- Device name
- Transept Cervical Plate System
- Applicant
- Neurostructures, Inc.
Irvine, CA, US - Received
- April 7, 2020
- Decision date
- July 24, 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 |
|---|---|---|
| K202190 | Oculus-SA Lumbar Cage SystemOVD · Traditional | 10/02/2020SE |
| K200115 | Cavetto-SA Cervical Cage SystemOVE · Special | 09/24/2020SE |
| K201769 | Cavetto [MAX] Cervical Cage SystemODP · Traditional | 09/03/2020SE |
| K192248 | Cortina [MAX] Lumbar Cage SystemMAX · Special | 11/25/2019SE |
| K182195 | Arco-SA Lumbar Cage SystemOVD · Special | 11/09/2018SE |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage SystemODP · Special | 11/08/2018SE |
| K173082 | Arco-SA Lumbar Cage SystemOVD · Traditional | 03/29/2018SE |
| K180431 | Cortina [MAX] Lumbar Cage SystemMAX · Traditional | 03/22/2018SE |
| K172320 | Neurostructures Cavetto® Cervical Cage SystemODP · Traditional | 02/26/2018SE |
| K173077 | Cavetto-SA Cervical Cage SystemOVE · Traditional | 02/23/2018SE |
Questions and answers
When was Transept Cervical Plate System cleared by the FDA?
Transept Cervical Plate System (K200927) received a 510(k) decision of Substantially Equivalent on July 24, 2020, 108 days after the submission was received.
What is the product code of K200927?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.