Cleared Special

Fine Osteotomy?

K253300 · Bodycad Laboratories, Inc. · Orthopedic
Oct 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K253300 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 October 28, 2025, 29 days after receiving the submission on September 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K253300 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date October 28, 2025
Days to Decision 29 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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