FDA.report

510(k) K253615

Device
Invictus Bands System
Applicant
Alphatec Spine, Inc.
510(k) number
K253615
Product code
OWI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-25
Date received
2025-11-18
Regulation
888.3010
Classification name
Bone Fixation Cerclage, Sublaminar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Griffin Riggs
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code OWI

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K222097OLYMPIC Deformity Band SystemAstura Medical2023-05-04
K230565HILINE™ Fixation SystemGlobus Medical, Inc.2023-04-20
K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA2022-05-24
K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.2021-05-27
K201240Mariner Cap SystemSeaSpine Orthopedics Corporation2020-08-05
K200281The Gecko Spinal SystemOrtho Development Corporation2020-03-31
K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.2020-03-16
K191217JAZZ PFImplanet, S.A.2019-08-02
K190289Karma® Fixation SystemSpinal Elements, Inc.2019-04-03
K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated2019-03-21
K180728Spinal Elements Cerclage SystemSpinal Elements, Inc.2018-09-06
K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas2018-08-29
K172206NAJA™ Ligament Correction SystemCousin Biotech Sas2018-04-10
K173506LigaPASSMedicrea International SA2018-04-03
K173117NuVasive® VersaTie™ SystemNuvasive, Inc.2017-12-07