Dakota ALIF Plate System
FDA 510(k) K212937 · Precision Spine, Inc.
510(k) numberK212937
Submission
- Device name
- Dakota ALIF Plate System
- Applicant
- Precision Spine, Inc.
Pear, MS, US - Received
- September 15, 2021
- Decision date
- November 4, 2021
- 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 |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250769 | Dakota LP SystemODP · Traditional | 11/24/2025SE |
| K242297 | Reform Pedicle Screw SystemNKB · Traditional | 12/17/2024SE |
| K231229 | S-COMP Reform® POCT Navigation InstrumentsOLO · Special | 05/25/2023SE |
| K220862 | E-GPS Navigated InstrumentsOLO · Traditional | 07/14/2022SE |
| K213118 | Dakota ALIF SystemOVD · Traditional | 04/01/2022SE |
| K220324 | AccuFit Lateral 2-Hole PlateKWQ · Traditional | 03/16/2022SE |
| K212075 | ShurFit Lumbar Interbody SystemMAX · Traditional | 12/08/2021SE |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemOVE · Traditional | 01/12/2021SE |
| K200303 | Reform Pedicle Screw SystemNKB · Traditional | 05/19/2020SE |
| K192494 | NexGen Anterior Cervical Plate SystemKWQ · Traditional | 10/29/2019SE |
Questions and answers
When was Dakota ALIF Plate System cleared by the FDA?
Dakota ALIF Plate System (K212937) received a 510(k) decision of Substantially Equivalent on November 4, 2021, 50 days after the submission was received.
What is the product code of K212937?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.