510(k) K171881

JAZZ Passer Band by Implanet, S.A. — Product Code OWI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 8, 2017
Date Received: June 23, 2017
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)
K191217 — JAZZ PF (August 2, 2019)
K182771 — ISS-JAZZ Screw System and JAZZ CAP SP (March 12, 2019)
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)
K191217 — JAZZ PF (August 2, 2019)
K190289 — Karma® Fixation System (April 3, 2019)
K190418 — NuVasive® VersaTie® System (March 21, 2019)