FDA.report

510(k) K241282

Device
RibFix Titan™ Fixation System
Applicant
Riverpoint Medical
510(k) number
K241282
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-19
Date received
2024-05-07
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Paul Vagts
Address
825 NE 25th Ave. Portland OR US 97232 97232

FDA Registration Numbers

Source Documents

510(k) summary PDF

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