FDA.report

510(k) K234116

Device
Trigon Trigon HA Stand-Alone Wedge Fixation System
Applicant
Nvision Biomedical Technologies
510(k) number
K234116
Product code
PLF
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-26
Date received
2023-12-27
Regulation
888.3030
Classification name
Bone Wedge
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Analaura Villarreal Berain
Address
4590 Lockhill Selma San Antonio TX US 78249 78249

FDA Registration Numbers

Source Documents

510(k) summary PDF

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