Trigon Ti Stand-Alone Wedge Fixation System— 510(k) K192645
Substantially EquivalentNvision Biomedical Technologies, Inc.
FDA 510(k) clearance K192645 for Trigon Ti Stand-Alone Wedge Fixation System, Substantially Equivalent on 2019-12-23. Applicant: Nvision Biomedical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Nvision Biomedical Technologies, Inc.
- Product code
- Code PLF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
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