510(k) K211057

LigaPASS® Spinal System, CD Horizon Spinal System by Medtronic, Inc. — Product Code OWI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 27, 2021
Date Received: April 9, 2021
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.

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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)
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)
K180728 — Spinal Elements Cerclage System (September 6, 2018)