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510(k) K192396

Streamline MIS Spinal Fixation System by Pioneer Surgical Technology, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2019
Date Received
September 3, 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.

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  • K222493 — CODA™ Anterior Cervical Plate System (November 18, 2022)
  • K211408 — CervAlign® Anterior Cervical Plate System (June 23, 2021)
  • K140696 — STREAMLINE TL SPINAL FIXATION SYSTEM (April 10, 2014)
  • K133455 — CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC (March 27, 2014)
  • K133623 — C-PLUS (February 10, 2014)
  • K132050 — NB3D BONE VOID FILLER (February 7, 2014)
  • K133785 — TRITIUM STERNAL CABLE PLATE SYSTEM (January 27, 2014)
  • K131724 — PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE (December 24, 2013)
  • K131100 — STREAMLINE TL SPINAL SYSTEM (June 27, 2013)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • 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)