Oria Cervical Plates
FDA 510(k) K023377 · Ortho Tec, LLC
510(k) numberK023377
Submission
- Device name
- Oria Cervical Plates
- Applicant
- Ortho Tec, LLC
California, CA, US - Received
- October 8, 2002
- Decision date
- March 4, 2003
- 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 |
|---|---|---|
| K040514 | Eovia Calcium Phosphate CeramicMQV · Traditional | 05/03/2004SE |
| K040346 | Modification to Oria Top Clip SystemMNI · Special | 03/12/2004SE |
| K030958 | Oria Spinal System, Domino and Tube ConnectorsMNI · Traditional | 11/20/2003SE |
| K031471 | Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01KWP · Traditional | 10/10/2003SE |
| K023884 | Modification Oria Spinal SystemKWP · Traditional | 08/20/2003SE |
| K023378 | Oria ClarisMNH · Traditional | 06/27/2003SE |
| K031452 | Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03KWP · Special | 06/18/2003SE |
| K030500 | Oria ZenithKWQ · Special | 03/20/2003SE |
| K030253 | Oria Spinal Clip System, Lengthened Lateral Connector, Model AL06KWP · Special | 02/21/2003SE |
| K030252 | Oria Spinal Clip System Extended Omniaxial Connectors (CO05 & CO07)KWP · Special | 02/21/2003SE |
Questions and answers
When was Oria Cervical Plates cleared by the FDA?
Oria Cervical Plates (K023377) received a 510(k) decision of Substantially Equivalent on March 4, 2003, 147 days after the submission was received.
What is the product code of K023377?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.