FDA.report

510(k) K203445

Device
Trigon HA Stand-Alone Wedge Fixation System
Applicant
Nvision Biomedical Technologies, Inc.
510(k) number
K203445
Product code
PLF
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-21
Date received
2020-11-23
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
Diana Langham
Address
4590 Lockhill Selma San Antonio TX US 78249 78249

FDA Registration Numbers

Source Documents

510(k) summary PDF

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