CETRA Anterior Cervical Plate System
FDA 510(k) K162638 · Orthofix, Inc.
510(k) numberK162638
Submission
- Device name
- CETRA Anterior Cervical Plate System
- Applicant
- Orthofix, Inc.
Lewisville, TX, US - Received
- September 22, 2016
- Decision date
- December 16, 2016
- 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
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|---|---|---|---|
| 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 |
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| K250112 | FitboneTM TrochantericHSB · Traditional | 04/10/2025SE |
| K242270 | OrthoNext Platform SystemQIH · Traditional | 12/19/2024SE |
| K242861 | TrueLok ElevateKTT · Traditional | 12/03/2024SE |
| K233867 | Fitbone TrochantericHSB · Traditional | 06/18/2024SE |
| K240749 | PILLAR SA Ti Spacer System (82-XXX)MAX · Traditional | 05/28/2024SE |
| K232648 | RODEO Telescopic NailHSB · Traditional | 05/03/2024SE |
| K232169 | FITBONE® Transport and Lengthening SystemHSB · Traditional | 03/22/2024SE |
| K213572 | JuniOrtho Plating SystemHWC · Traditional | 01/18/2022SE |
Questions and answers
When was CETRA Anterior Cervical Plate System cleared by the FDA?
CETRA Anterior Cervical Plate System (K162638) received a 510(k) decision of Substantially Equivalent on December 16, 2016, 85 days after the submission was received.
What is the product code of K162638?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.