Regent Anterior Cervical Plate
FDA 510(k) K101151 · Custom Spine
510(k) numberK101151
Submission
- Device name
- Regent Anterior Cervical Plate
- Applicant
- Custom Spine
Parsippany, NJ, US - Received
- April 23, 2010
- Decision date
- May 19, 2010
- 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.
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| K143143 | Pathway ElifMAX · Traditional | 07/22/2015SE |
| K132596 | Proposed OptimusOVD · Traditional | 04/11/2014SE |
| K120597 | KompredaMRW · Traditional | 05/03/2013SE |
| K111726 | Pathway AvidMAX · Traditional | 02/06/2012SE |
| K111774 | Pathway Model 07XXXXMAX · Special | 07/20/2011SE |
| K111099 | Issys LP Spinal Fixation SystemNKB · Special | 05/05/2011SE |
| K092904 | Pathway Ivb/VbrODP · Traditional | 12/22/2009SE |
| K091134 | Custom Spine Regent Anterior Cervical PlateKWQ · Traditional | 08/17/2009SE |
| K090566 | Pathway AvidMAX · Traditional | 06/01/2009SE |
| K080281 | PathwayMAX · Traditional | 05/01/2008SE |
Questions and answers
When was Regent Anterior Cervical Plate cleared by the FDA?
Regent Anterior Cervical Plate (K101151) received a 510(k) decision of Substantially Equivalent on May 19, 2010, 26 days after the submission was received.
What is the product code of K101151?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.