BODYCAD LABORATORIES, INC.

FDA Device Registration & Listing · Quebec, CA · Registration 3012086398

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012086398
FEI Number
3012086398
Entity Name
BODYCAD LABORATORIES, INC.
City/State/Country
Quebec, CA
Establishment Address
2035 rue du Haut-Bord, Quebec G1N 4R7, CA
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Bodycad Laboratories, Inc. (Owner Number: 10051292)
Owner / Operator Contact Address
2035 rue du Haut-Bord, Québec, CA-QC G1N 4R7, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

4.5 mm Countersink Fine Osteotomy Bodycad Laboratories Inc. Bodycad Laboratories Inc. Fine TTO Bodycad Laboratories Inc. Bodycad Bodycad OnCall system-Custom Device Bodycad OnCall system-Custom Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWW Countersink Orthopedic Class 1 888.4540 2026-02-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-27
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2025-11-27
HXX Screwdriver Orthopedic Class 1 888.4540 2023-02-20
HTW Bit, Drill Orthopedic Class 1 888.4540 2023-02-16
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2025-11-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-27
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2023-02-20
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-02-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-07-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-07-10

Official Correspondent

Nadine Adia

US Agent Details

Randall Kevin M. Business: ComplianceAcuity, Inc. Email: kevin@complianceacuity.com Phone: (303) 8280844

Related Public Records

Same Entity

Bodycad Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012086398. Last updated year: 2026. Please use registration number 3012086398 when referencing this establishment in official correspondence.
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