FDA Registration
Active
🇨🇦 Canada
BODYCAD LABORATORIES, INC.
Reg #: 3012086398
·
FEI: 3012086398
·
Expires 2026
Products
10
Proprietary Names
6
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- BODYCAD LABORATORIES, INC.
- Registration Number
- 3012086398
- FEI Number
- 3012086398
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2035 rue du Haut-Bord
- City
- Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K253300
Owner / Operator
- Firm Name
- Bodycad Laboratories, Inc.
- Operator Number
- 10051292
- Address
- 2035 rue du Haut-Bord
- City
- Québec
- State
- Quebec
- Postal Code
- G1N 4R7
- Country
- CA
- Correspondent
- Nadine Adia
US Agent
- Business Name
- ComplianceAcuity, Inc.
- Contact Name
- Randall Kevin M.
- Address
- 485 Clinton St, 888
- City
- Ridgway
- State
- CO
- ZIP
- 81432
- Country
- US
- [email protected]
- Phone
- 303 8280844
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Countersink | HWW | Class 1 | Orthopedic | No | 2026-02-23 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-11-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-11-27 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2025-11-27 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-02-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-02-16 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2023-02-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-02-29 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2023-02-13 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2023-02-16 |
Proprietary Names
4.5 mm Countersink
Fine Osteotomy
Bodycad Laboratories Inc.
Fine TTO
Bodycad
Bodycad OnCall system-Custom Device
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device