Cleared Special

BPS Wrist Fracture System

K250498 · Orthonovis, Inc. · Orthopedic
Mar 2025
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K250498 is an FDA 510(k) clearance for the BPS Wrist Fracture System, 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 March 17, 2025, 25 days after receiving the submission on February 20, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250498 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2025
Decision Date March 17, 2025
Days to Decision 25 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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