K232878

TransLoc 3D

510(k) number
K232878
Device name
TransLoc 3D
Applicant
Foundation Fusion Solutions, LLC (Dba Cornerloc) OK · US
Product code
OUR — Sacroiliac Joint Fixation
Decision date
2023-10-17
Date received
2023-09-18
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K232878.pdf

Official FDA record: K232878
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.