FDA.report

510(k) K232275

Device
Invictus® Spinal Fixation System
Applicant
Alphatec Spine, Inc.
510(k) number
K232275
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-27
Date received
2023-07-31
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
Cynthia Dorne
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
00190376711447InvictusALPHATEC SPINE, INC.2025-11-17
00190376711454InvictusALPHATEC SPINE, INC.2025-11-17
00190376182520InvictusALPHATEC SPINE, INC.2025-07-18
00190376135380InvictusALPHATEC SPINE, INC.2025-07-18
00190376139920InvictusALPHATEC SPINE, INC.2025-07-18
00190376141015InvictusALPHATEC SPINE, INC.2025-07-18
00190376140131InvictusALPHATEC SPINE, INC.2025-07-18
00190376182872InvictusALPHATEC SPINE, INC.2025-07-18
00190376139739InvictusALPHATEC SPINE, INC.2025-07-18
00190376135403InvictusALPHATEC SPINE, INC.2025-07-18
00190376135410InvictusALPHATEC SPINE, INC.2025-07-18
00190376183497InvictusALPHATEC SPINE, INC.2025-07-18
00190376135373InvictusALPHATEC SPINE, INC.2025-07-18
00190376182483InvictusALPHATEC SPINE, INC.2025-07-18
00190376135397InvictusALPHATEC SPINE, INC.2025-07-18
00190376539249InvictusALPHATEC SPINE, INC.2025-06-23
00190376539096InvictusALPHATEC SPINE, INC.2025-06-23
00190376539256InvictusALPHATEC SPINE, INC.2025-06-23
00190376652221InvictusALPHATEC SPINE, INC.2025-06-23
00190376539188InvictusALPHATEC SPINE, INC.2025-06-23
00190376539157InvictusALPHATEC SPINE, INC.2025-06-23
00190376539102InvictusALPHATEC SPINE, INC.2025-06-23
00190376652252InvictusALPHATEC SPINE, INC.2025-06-23
00190376539089InvictusALPHATEC SPINE, INC.2025-06-23
00190376652214InvictusALPHATEC SPINE, INC.2025-06-23
00190376539201InvictusALPHATEC SPINE, INC.2025-06-23
00190376652276InvictusALPHATEC SPINE, INC.2025-06-23
00190376652269InvictusALPHATEC SPINE, INC.2025-06-23
00190376539140InvictusALPHATEC SPINE, INC.2025-06-23
00190376539195InvictusALPHATEC SPINE, INC.2025-06-23

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