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510(k) K250769

Dakota LP System by Precision Spine, Inc. — Product Code ODP

K250769 is an FDA 510(k) premarket notification submitted by Precision Spine, Inc. for the device "Dakota LP System". The FDA issued a decision of Substantially Equivalent on November 24, 2025. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Precision Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2025
Date Received
March 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Precision Spine, Inc.

  • K242297 — Reform Pedicle Screw System (December 17, 2024)
  • K231229 — S-COMP Reform® POCT Navigation Instruments (May 25, 2023)
  • K220862 — E-GPS Navigated Instruments (July 14, 2022)
  • K213118 — Dakota ALIF System (April 1, 2022)
  • K220324 — AccuFit Lateral 2-Hole Plate (March 16, 2022)
  • K212075 — ShurFit Lumbar Interbody System (December 8, 2021)
  • K212937 — Dakota ALIF Plate System (November 4, 2021)
  • K203129 — NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System (January 12, 2021)
  • K200303 — Reform Pedicle Screw System (May 19, 2020)
  • K192494 — NexGen Anterior Cervical Plate System (October 29, 2019)

Other clearances for product code ODP

  • K262595 — VariLift-C Cervical Interbody Fusion System (August 26, 2026)
  • K262489 — BluEX Cervical Expandable Cage System (August 18, 2026)
  • K253041 — 3d Cage Cervical (July 23, 2026)
  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)

FDA data resources