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510(k) K242297

Reform Pedicle Screw System by Precision Spine, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2024
Date Received
August 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Precision Spine, Inc.

  • K250769 — Dakota LP System (November 24, 2025)
  • 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 NKB

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  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)