K192645 is an FDA 510(k) clearance for the Trigon? Ti Stand-Alone Wedge Fixation System. This device is classified as a Bone Wedge (Class II - Special Controls, product code PLF).
Submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 23, 2019, 90 days after receiving the submission on September 24, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia..
| 510(k) Number | K192645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2019 |
| Decision Date | December 23, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLF — Bone Wedge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia. |