510(k) K213659

LigaPASS 2.0 Ligament Augmentation System by Medicrea International SA — Product Code OWI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 24, 2022
Date Received: November 19, 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.

Other clearances by Medicrea International SA

K220810 — Infinity OCT System and PASS OCT Spinal System (April 19, 2022)
K220724 — CD Horizon Spinal System and PASS LP Spinal System (April 8, 2022)
K212005 — UNiD Spine Analyzer (January 12, 2022)
K213281 — PASS LP Spinal System, CD Horizon Spinal System (January 5, 2022)
K210470 — C-CURVE Interbody Fusion Device (September 3, 2021)
K200316 — UNiD IB3D ALIF (October 30, 2020)
K191134 — IB3D ALIF (October 30, 2019)
K182158 — UNiD Patient-matched PLIF cage (July 15, 2019)
K190092 — UNiD Patient specific 3D printed TLIF cage (May 8, 2019)
K190376 — PASS LP Spinal System (May 2, 2019)

Other clearances for product code OWI

K222097 — OLYMPIC Deformity Band System (May 4, 2023)
K230565 — HILINE Fixation System (April 20, 2023)
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)
K180728 — Spinal Elements Cerclage System (September 6, 2018)