Cleared Special

Fine Osteotomy?

K240703 · Bodycad Laboratories, Inc. · Orthopedic
Apr 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K240703 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 April 12, 2024, 29 days after receiving the submission on March 14, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K240703 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2024
Decision Date April 12, 2024
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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