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510(k) K170255

Device
Threshold™ V2 Pedicular Fixation System
Applicant
SPINEOLOGY INC.
510(k) number
K170255
Product code
NKB  
Decision
Substantially Equivalent (SESE)
Decision date
2017-04-14
Date received
2017-01-27
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
JACQUELINE HAUGE
Address
7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128

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
K262731Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation2026-10-29
K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.2026-10-02
K263062NOVIX Pedicle Screw SystemTdm Co., Ltd.2026-10-01
K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC2026-09-30
K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.2026-09-30
K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.2026-09-27
K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.2026-09-23
K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi2026-09-17
K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical2026-09-14
K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-09-04
K253943Tiger 2 SystemZavation Medical Products, LLC2026-07-24
K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.2026-07-24
K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.2026-07-14
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-07-01
K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.2026-06-17

Legacy Summary#

summary

FDA Review#

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