FDA.reportPublic FDA data

510(k) K230974

Device
NIDO? Pedicle Screw System
Applicant
Kalitec Medical
510(k) number
K230974
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-15
Date received
2023-04-05
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
Keith Cannon
Address
618 E. S. St., Suite 500 Orlando FL US 32801 32801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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