510(k) K163181

TRANSLACE Spinal Tethering System by Medtronic Sofamor Danek USA, Inc. — Product Code OWI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 16, 2017
Date Received: November 14, 2016
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 Medtronic Sofamor Danek USA, Inc.

K254165 — Infinity OCT System (January 21, 2026)
K253941 — CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) (January 7, 2026)
K253335 — CD Horizon Spinal System (October 24, 2025)
K253129 — Infinity OCT System (October 24, 2025)
K251444 — Endoskeleton Interbody Systems (September 4, 2025)
K251395 — The Rialto SI Fusion System (June 26, 2025)
K250669 — Adaptix Interbody System with Titan nanoLOCK Surface Technology (April 22, 2025)
K241992 — Catalyft LS Expandable Interbody System (October 28, 2024)
K243007 — CD Horizon Spinal System (October 23, 2024)
K233951 — CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (March 27, 2024)

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)