K260073

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

510(k) number
K260073
Device name
XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
Applicant
Biodynamik, Inc. CA · US
Product code
JDW — Pin, Fixation, Threaded
Decision date
2026-02-10
Date received
2026-01-09
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K260073.pdf

Official FDA record: K260073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.