Data / Medical devices / Canada / Bodycad Laboratories, Inc.

Bodycad Laboratories, Inc.: FDA-registered device maker in Quebec, Canada, 2 510(k) clearances

Name: Bodycad Laboratories, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bodycad Laboratories, Inc. is registered with the FDA (registration 3012086398) in Quebec, Canada. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 28, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012086398
Address: 2035 rue du Haut-Bord, Quebec, Canada, G1N 4R7
Owner or operator: Bodycad Laboratories, Inc. (10051292)
Roles: Complaint file establishment, Manufacturer
First device listed: February 29, 2016
Registered through: 2026
Brand names listed: 4.5 mm Countersink, Bodycad, Bodycad Laboratories Inc., Bodycad OnCall system-Custom Device, Fine Osteotomy, Fine TTO

Devices it lists

Device	Product code	Class	Role	Source
Bit, Drill	HTW	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Countersink	HWW	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Hammer, Surgical	FZY	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopaedic Surgical Planning And Instrument Guides	PBF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 28, 2025	K253300	Fine Osteotomy	HRS	Substantially Equivalent	Bodycad Laboratories, Inc.	accessdata.fda.gov
October 21, 2025	K250394	Fine TTO	PBF	Substantially Equivalent	Bodycad Laboratories, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 2, 2021	88878	Class II	Terminated	Torque Limiting Adaptor, AO Connect, 4 N-m, part #, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #.	There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.	accessdata.fda.gov

Compare with other makers

Updated October 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.