FDA.report

510(k) K231496

Device
TITAN 3-D Wedge System
Applicant
Paragon 28, Inc.
510(k) number
K231496
Product code
PLF
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-22
Date received
2023-05-24
Regulation
888.3030
Classification name
Bone Wedge
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

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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