Cleared Traditional

Fine Osteotomy?

K250923 · Bodycad Laboratories, Inc. · Orthopedic
Aug 2025
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K250923 is an FDA 510(k) clearance for the Fine Osteotomy?, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Bodycad Laboratories, Inc. (Quebec, CA). The FDA issued a Cleared decision on August 21, 2025, 147 days after receiving the submission on March 27, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250923 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2025
Decision Date August 21, 2025
Days to Decision 147 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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