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510(k) K201497

EVOS Cabling System by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2020
Date Received
June 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

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

  • K193468 — Tritium Sternal Cable Plate System (March 12, 2020)
  • 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)
  • 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 JDQ

  • K243905 — Stitch Cerclage – Suture Tapes (August 14, 2025)
  • K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape C (February 20, 2025)
  • K232733 — Mbrace Cable (May 3, 2024)
  • K233949 — ACCORD Cable System (March 13, 2024)
  • K232986 — VariTrax Sternal CircumFixation System (January 30, 2024)
  • K230976 — Arthrex Radiopaque FiberTape Cerclage sutures (August 24, 2023)
  • K231333 — STRETTO™ Cable System (August 4, 2023)
  • K220765 — HS Fiber Cerclage (July 26, 2023)
  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
  • K211613 — Stern Fix Sternal Stabilization System (January 19, 2022)