FDA.reportPublic FDA data

510(k) K242764

Device
MediRod Pedicle Screw System
Applicant
Cmf Medicon Surgical, Inc.
510(k) number
K242764
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-13
Date received
2024-09-13
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
Matthias Alber
Address
112000 St. Johns Industrial Pkwy. N Suite 1 Jacksonville FL US 32246 32246

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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