Slimplicity Solo Anterior Cervical Plate System
FDA 510(k) K112748 · Spinal USA, LLC
510(k) numberK112748
Submission
- Device name
- Slimplicity Solo Anterior Cervical Plate System
- Applicant
- Spinal USA, LLC
Pear, MS, US - Received
- September 21, 2011
- Decision date
- July 11, 2012
- 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 |
|---|---|---|
| K132029 | Vault-C Intervertebral Body Fusion DeviceOVE · Traditional | 11/25/2013SE |
| K130863 | Facet Screw SystemMRW · Traditional | 08/09/2013SE |
| K131343 | Reform Pedicle Screw SystemMNI · Traditional | 07/24/2013SE |
| K130279 | Reform Pedicle Screw SystemMNI · Traditional | 06/20/2013SE |
| K130445 | Vault Alif SystemOVD · Special | 04/25/2013SE |
| K122931 | S-Lok PSS SystemMNI · Traditional | 11/20/2012SE |
| K121172 | Reform Pedicle Screw SystemMNI · Special | 08/08/2012SE |
| K112025 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Traditional | 09/15/2011SE |
| K103369 | Vault Alif SystemOVD · Traditional | 04/04/2011SE |
| K092659 | Spinal USA RCS Anterior Lumbar Butress Plate System, Model 22-1001-25KWQ · Traditional | 11/17/2009SE |
Questions and answers
When was Slimplicity Solo Anterior Cervical Plate System cleared by the FDA?
Slimplicity Solo Anterior Cervical Plate System (K112748) received a 510(k) decision of Substantially Equivalent on July 11, 2012, 294 days after the submission was received.
What is the product code of K112748?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.