Cleared Traditional

TriMed Wrist Fixation System 3

K222637 · TriMed, Inc. · Orthopedic
Dec 2022
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K222637 is an FDA 510(k) clearance for the TriMed Wrist Fixation System 3, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on December 21, 2022, 112 days after receiving the submission on August 31, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K222637 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2022
Decision Date December 21, 2022
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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