510(k) K203445
K203445 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies, Inc. for the device "Trigon HA Stand-Alone Wedge Fixation System". The FDA issued a decision of Substantially Equivalent on December 21, 2020. The device falls under product code PLF (Bone Wedge), a Class II device regulated under 21 CFR 888.3030. Nvision Biomedical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2020
- Date Received
- November 23, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Wedge
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.