Spinesmith Partners, LP Cequence Anterior Cervical Plate System
FDA 510(k) K082821 · Spine Smith Partners L.P.
510(k) numberK082821
Submission
- Device name
- Spinesmith Partners, LP Cequence Anterior Cervical Plate System
- Applicant
- Spine Smith Partners L.P.
Austin, TX, US - Received
- September 25, 2008
- Decision date
- October 31, 2008
- 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 |
|---|---|---|
| K122630 | IN:C2 Spinal Fixation SystemOVE · Special | 12/05/2012SE |
| K122168 | Visualif Challenging Access PlateOVD · Special | 10/11/2012SE |
| K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemOVD · Special | 09/30/2010SE |
| K101085 | Spinesmith Cynch Spinal SystemMAX · Special | 07/01/2010SE |
| K090376 | Spinesmith Cynch Spinal SystemMAX · Traditional | 04/01/2009SE |
| K081132 | Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional | 07/14/2008SE |
| K080971 | Spinesmith Cimplicity Spinal SystemMQP · Traditional | 07/02/2008SE |
| K073320 | Cimplicity Spinal SystemODP · Traditional | 02/07/2008SE |
Questions and answers
When was Spinesmith Partners, LP Cequence Anterior Cervical Plate System cleared by the FDA?
Spinesmith Partners, LP Cequence Anterior Cervical Plate System (K082821) received a 510(k) decision of Substantially Equivalent on October 31, 2008, 36 days after the submission was received.
What is the product code of K082821?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.