Cleared Special

BPS - Bone Fragment Fixation Plates, Screws and Washers

K250055 · Orthonovis, Inc. · Orthopedic
Feb 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K250055 is an FDA 510(k) clearance for the BPS - Bone Fragment Fixation Plates, Screws and Washers, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Orthonovis, Inc. (Palm Coast, US). The FDA issued a Cleared decision on February 6, 2025, 27 days after receiving the submission on January 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250055 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2025
Decision Date February 06, 2025
Days to Decision 27 days
Submission Type Special
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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