Dakota ALIF System
FDA 510(k) K213118 · Precision Spine, Inc.
510(k) numberK213118
Submission
- Device name
- Dakota ALIF System
- Applicant
- Precision Spine, Inc.
Pear, MS, US - Received
- September 27, 2021
- Decision date
- April 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
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| 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 |
| K220324 | AccuFit Lateral 2-Hole PlateKWQ · Traditional | 03/16/2022SE |
| K212075 | ShurFit Lumbar Interbody SystemMAX · Traditional | 12/08/2021SE |
| K212937 | Dakota ALIF Plate SystemKWQ · Traditional | 11/04/2021SE |
| 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 System cleared by the FDA?
Dakota ALIF System (K213118) received a 510(k) decision of Substantially Equivalent on April 1, 2022, 186 days after the submission was received.
What is the product code of K213118?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.