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510(k) K192800

Streamline TL Spinal Fixation System by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) — Product Code NKB

K192800 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) for the device "Streamline TL Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on January 14, 2020. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2020
Date Received
September 30, 2019
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 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

  • K201497 — EVOS Cabling System (October 28, 2020)
  • K193468 — Tritium Sternal Cable Plate System (March 12, 2020)
  • K183060 — CervAlign™ Anterior Cervical Plate System (January 17, 2019)
  • K172139 — Streamline OCT Occipito-Cervico-Thoracic System (August 18, 2017)
  • K161498 — Streamline OCT Occipito-Cervico-Thoracic System (August 22, 2016)
  • K153735 — Release Laminoplasty Fixation System (January 21, 2016)
  • K150581 — Tritium Sternal Cable Plate System (June 4, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)

Other clearances for product code NKB

  • 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)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources