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510(k) K173814

DeGen Medical E3 MIS Pedicle Screw System by Degen Medical — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2018
Date Received
December 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
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  • K253335 — CD Horizon™ Spinal System (October 24, 2025)