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510(k) K191217

JAZZ PF by Implanet, S.A. — Product Code OWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2019
Date Received
May 6, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

Other clearances by Implanet, S.A.

  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K252437 — JAZZ Spinal System (August 28, 2025)
  • K240392 — JAZZ Spinal System (May 6, 2024)
  • K230026 — SQUALE (March 28, 2023)
  • K192084 — Madison Total Knee System (October 22, 2019)
  • K182771 — ISS-JAZZ Screw System and JAZZ CAP SP (March 12, 2019)
  • K171881 — JAZZ Passer Band (August 8, 2017)
  • K170730 — JAZZ System, including JAZZ Band (June 9, 2017)
  • K162764 — JAZZ FRAME SYSTEM (January 19, 2017)
  • K160226 — JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector (May 18, 2016)

Other clearances for product code OWI

  • K222097 — OLYMPIC Deformity Band System (May 4, 2023)
  • K230565 — HILINE™ Fixation System (April 20, 2023)
  • K213659 — LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
  • K211057 — LigaPASS® Spinal System, CD Horizon™ Spinal System (May 27, 2021)
  • K201240 — Mariner Cap System (August 5, 2020)
  • K200281 — The Gecko Spinal System (March 31, 2020)
  • K200097 — Response BandLoc Spinal Fixation (March 16, 2020)
  • K190289 — Karma® Fixation System (April 3, 2019)
  • K190418 — NuVasive® VersaTie® System (March 21, 2019)
  • K180728 — Spinal Elements Cerclage System (September 6, 2018)