Cleared Traditional

MSFX MIKRON PEEK CAGES

K252781 · Mikron Makina Sanayi VE Tic. Ltd. Sti. · Orthopedic

Dec 2025

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K252781 is an FDA 510(k) clearance for the MSFX MIKRON PEEK CAGES, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Mikron Makina Sanayi VE Tic. Ltd. Sti. (Yenimahalle, TR). The FDA issued a Cleared decision on December 19, 2025, 108 days after receiving the submission on September 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K252781 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2025
Decision Date	December 19, 2025
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.