FDA.reportPublic FDA data

510(k) K251131

Device
Annex® 2 Adjacent Level System
Applicant
Spine Wave, Inc.
510(k) number
K251131
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-06
Date received
2025-04-11
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
No

Applicant Contact#

Contact
Ronald Smith
Address
Three Enterprise Dr. Suite 210 Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKB#

510(k), Device, Applicant table
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