Cleared Special

Fine Osteotomy?

K240066 · Bodycad Laboratories, Inc. · Orthopedic

Feb 2024

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K240066 is an FDA 510(k) clearance for the Fine Osteotomy?, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Bodycad Laboratories, Inc. (Quebec, CA). The FDA issued a Cleared decision on February 9, 2024, 31 days after receiving the submission on January 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K240066 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 09, 2024
Decision Date	February 09, 2024
Days to Decision	31 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PBF — Orthopaedic Surgical Planning And Instrument Guides
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.