Home / 510(k) Clearances / K120724

510(k) K120724

PIONEER LATERAL PLATE SYSTEM by Pioneer Surgical Technology, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2012
Date Received
March 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Pioneer Surgical Technology, Inc.

  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K222493 — CODA™ Anterior Cervical Plate System (November 18, 2022)
  • K211408 — CervAlign® Anterior Cervical Plate System (June 23, 2021)
  • K192396 — Streamline MIS Spinal Fixation System (November 26, 2019)
  • 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)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)