Trigon HA Stand-Alone Wedge Fixation System
FDA 510(k) K193414 · Nvision Biomedical Technologies, Inc.
510(k) numberK193414
Submission
- Device name
- Trigon HA Stand-Alone Wedge Fixation System
- Applicant
- Nvision Biomedical Technologies, Inc.
San Antonio, TX, US - Received
- December 9, 2019
- Decision date
- February 25, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLF – Bone Wedge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
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Questions and answers
When was Trigon HA Stand-Alone Wedge Fixation System cleared by the FDA?
Trigon HA Stand-Alone Wedge Fixation System (K193414) received a 510(k) decision of Substantially Equivalent on February 25, 2020, 78 days after the submission was received.
What is the product code of K193414?
The FDA product code is PLF – Bone Wedge, a Class II (moderate risk) device regulated under 21 CFR 888.3030.