Cleared Special

Trigon PEEK HA Wedges

K243231 · Nvision Biomedical Technologies · Orthopedic

Nov 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K243231 is an FDA 510(k) clearance for the Trigon PEEK HA Wedges, a Bone Wedge (Class II — Special Controls, product code PLF), submitted by Nvision Biomedical Technologies (San Antonio, US). The FDA issued a Cleared decision on November 8, 2024, 30 days after receiving the submission on October 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K243231 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2024
Decision Date	November 08, 2024
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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.