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510(k) K231231

Device
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
Applicant
Paragon 28, Inc.
510(k) number
K231231
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-12
Date received
2023-04-28
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Haylie Hertz
Address
14445 Grasslands Dr. Englewood CO US 80112 80112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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