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OWI — Bone Fixation Cerclage, Sublaminar Class II

FDA Device Classification

Classification Details

Product Code
OWI
Device Class
Class II
Regulation Number
888.3010
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222097astura medicalOLYMPIC Deformity Band SystemMay 4, 2023
K230565globus medicalHILINE™ Fixation SystemApril 20, 2023
K213659medicrea internationalLigaPASS™ 2.0 Ligament Augmentation SystemMay 24, 2022
K211057medtronicLigaPASS® Spinal System, CD Horizon™ Spinal SystemMay 27, 2021
K201240seaspine orthopedics corporationMariner Cap SystemAugust 5, 2020
K200281ortho development corporationThe Gecko Spinal SystemMarch 31, 2020
K200097orthopediatricsResponse BandLoc Spinal FixationMarch 16, 2020
K191217implanetJAZZ PFAugust 2, 2019
K190289spinal elementsKarma® Fixation SystemApril 3, 2019
K190418nu vasive, incorporatedNuVasive® VersaTie® SystemMarch 21, 2019
K180728spinal elementsSpinal Elements Cerclage SystemSeptember 6, 2018
K181799cousin biotechResCUBE™ Ligament Fixation SystemAugust 29, 2018
K172206cousin biotechNAJA™ Ligament Correction SystemApril 10, 2018
K173506medicrea internationalLigaPASSApril 3, 2018
K173117nuvasiveNuVasive® VersaTie™ SystemDecember 7, 2017
K172417globus medicalSILC® Fixation SystemOctober 26, 2017
K172021medicrea internationalLigaPASSAugust 30, 2017
K171881implanetJAZZ Passer BandAugust 8, 2017
K170730implanetJAZZ System, including JAZZ BandJune 9, 2017
K163181medtronic sofamor danek usaTRANSLACE™ Spinal Tethering SystemMay 16, 2017