FDA.report

510(k) K241519

Device
Invictus® Small Stature Spinal Fixation System
Applicant
Alphatec Spine, Inc.
510(k) number
K241519
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-21
Date received
2024-05-29
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
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
Andrew Zhang
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

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376629056InvictusALPHATEC SPINE, INC.2025-11-25
00190376629087InvictusALPHATEC SPINE, INC.2025-11-25
00190376651743InvictusALPHATEC SPINE, INC.2025-11-25
00190376629155InvictusALPHATEC SPINE, INC.2025-11-25
00190376629117InvictusALPHATEC SPINE, INC.2025-11-25
00190376629094InvictusALPHATEC SPINE, INC.2025-11-25
00190376629148InvictusALPHATEC SPINE, INC.2025-11-25
00190376651736InvictusALPHATEC SPINE, INC.2025-11-25
00190376651699InvictusALPHATEC SPINE, INC.2025-11-25
00190376629162InvictusALPHATEC SPINE, INC.2025-11-25
00190376629070InvictusALPHATEC SPINE, INC.2025-11-25
00190376629018InvictusALPHATEC SPINE, INC.2025-11-25
00190376651774InvictusALPHATEC SPINE, INC.2025-11-25
00190376651750InvictusALPHATEC SPINE, INC.2025-11-25
00190376628974InvictusALPHATEC SPINE, INC.2025-11-25
00190376629063InvictusALPHATEC SPINE, INC.2025-11-25
00190376629025InvictusALPHATEC SPINE, INC.2025-11-25
00190376628998InvictusALPHATEC SPINE, INC.2025-11-25
00190376651729InvictusALPHATEC SPINE, INC.2025-11-25
00190376629124InvictusALPHATEC SPINE, INC.2025-11-25
00190376629100InvictusALPHATEC SPINE, INC.2025-11-25
00190376651705InvictusALPHATEC SPINE, INC.2025-11-25
00190376629032InvictusALPHATEC SPINE, INC.2025-11-25
00190376628981InvictusALPHATEC SPINE, INC.2025-11-25
00190376651767InvictusALPHATEC SPINE, INC.2025-11-25
00190376629049InvictusALPHATEC SPINE, INC.2025-11-25
00190376651682InvictusALPHATEC SPINE, INC.2025-11-25
00190376629131InvictusALPHATEC SPINE, INC.2025-11-25
00190376629001InvictusALPHATEC SPINE, INC.2025-11-25
00190376651712InvictusALPHATEC SPINE, INC.2025-11-25

Other 510(k) Records For Product Code NKB

510(k)DeviceApplicantDecision date
K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)2026-05-15
K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ SystemGlobus Medical, Inc.2026-05-07
K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2026-05-05
K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2026-05-01
K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-29
K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2026-04-28
K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2026-04-21
K254274ARx® SAI Implant SystemLife Spine, Inc.2026-04-16
K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-04-03
K254247OSTEOMNI SPINAL FIXATION SYSTEMOsteomni, Inc.2026-02-24
K253169Duet™ Spinal Fixation SystemBox Spine, LLC2026-02-23
K253545Vulcan Spinal SystemK2m, Inc.2026-02-10
K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.2026-01-13
K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-01-07
K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.2026-01-07