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510(k) K153735

Release Laminoplasty Fixation System by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2016
Date Received
December 28, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

Other clearances by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

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  • K192800 — Streamline TL Spinal Fixation System (January 14, 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)
  • K150581 — Tritium Sternal Cable Plate System (June 4, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)

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  • K231232 — Curiteva Laminoplasty System (June 28, 2023)
  • K212428 — Centerpiece Plate Fixation System (December 13, 2021)
  • K191927 — Hinged Laminoplasty System (September 20, 2019)
  • K191169 — NuVasive® Camber Laminoplasty System (July 3, 2019)
  • K181717 — Life Spine Laminoplasty System (October 12, 2018)
  • K173215 — Choice Spine Laminoplasty™ Fixation System (January 19, 2018)
  • K171413 — HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (July 14, 2017)