Raven Lumbar Plate System
FDA 510(k) K183214 · Choicespine, LP
510(k) numberK183214
Submission
- Device name
- Raven Lumbar Plate System
- Applicant
- Choicespine, LP
Knoxville, TN, US - Received
- November 19, 2018
- Decision date
- January 3, 2019
- 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 |
|---|---|---|
| K190227 | Boomerang Anterior Cervical Plate SystemKWQ · Traditional | 05/01/2019SE |
| K183397 | ChoiceSpine Stealth Cervical Spacer SystemODP · Special | 03/06/2019SE |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Special | 02/22/2019SE |
| K182721 | Choice Spine Navigation SystemOLO · Traditional | 01/08/2019SE |
| K180519 | HARRIER-SA Lumbar Interbody SystemOVD · Traditional | 05/16/2018SE |
| K172816 | TiGer Shark SystemMAX · Traditional | 01/26/2018SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | 01/19/2018SE |
| K171489 | Acapella Cervical Spacer SystemOVE · Traditional | 10/23/2017SE |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Traditional | 09/15/2017SE |
| K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw SystemsNKB · Traditional | 08/03/2017SE |
Questions and answers
When was Raven Lumbar Plate System cleared by the FDA?
Raven Lumbar Plate System (K183214) received a 510(k) decision of Substantially Equivalent on January 3, 2019, 45 days after the submission was received.
What is the product code of K183214?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.