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510(k) K200303

Reform Pedicle Screw System by Precision Spine — Product Code NKB

K200303 is an FDA 510(k) premarket notification submitted by Precision Spine for the device "Reform Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on May 19, 2020. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Precision Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2020
Date Received
February 6, 2020
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

  • K250769 — Dakota LP System (November 24, 2025)
  • 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)
  • K192494 — NexGen Anterior Cervical Plate System (October 29, 2019)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources