Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K242764

MediRod Pedicle Screw System

510(k) number
K242764
Device name
MediRod Pedicle Screw System
Applicant
Cmf Medicon Surgical, Inc. FL · US
Product code
NKB — Thoracolumbosacral Pedicle Screw System
Decision date
2024-11-13
Date received
2024-09-13
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
510(k) Summary (official FDA PDF): K242764.pdf
Official FDA record: K242764
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.