C-Tek C-Trun Anterior Cervical Plate System
FDA 510(k) K042798 · Interpore Cross Intl.
510(k) numberK042798
Submission
- Device name
- C-Tek C-Trun Anterior Cervical Plate System
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- October 8, 2004
- Decision date
- November 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K050861 | PEEK CasMQP · Special | 05/27/2005SE |
| K031399 | Intergro DBMMQV · Traditional | 02/18/2005SE |
| K041407 | Titanium Mesh ImplantMQP · Traditional | 12/29/2004SE |
| K043229 | Modification to Altius Oct SystemKWP · Special | 12/21/2004SE |
| K040928 | Expandable PEEK VBR ImplantMQP · Traditional | 08/27/2004SE |
| K041794 | C-Tek C-Thru Anterior Cervical Plate SystemKWQ · Special | 07/19/2004SE |
| K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatKWP · Special | 07/01/2004SE |
| K033961 | Altius Oct SystemKWP · Special | 04/14/2004SE |
| K040168 | Modification to Geo StructureMQP · Special | 04/08/2004SE |
| K031772 | Ti Fenestrated PlateKWP · Abbreviated | 09/05/2003SE |
Questions and answers
When was C-Tek C-Trun Anterior Cervical Plate System cleared by the FDA?
C-Tek C-Trun Anterior Cervical Plate System (K042798) received a 510(k) decision of Substantially Equivalent on November 4, 2004, 27 days after the submission was received.
What is the product code of K042798?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.