FDA Registration
Active
🇬🇧 United Kingdom
DEPUY CMW
Reg #: 9610921
·
FEI: 3002806724
·
Expires 2026
Products
18
Proprietary Names
22
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- DEPUY CMW
- Registration Number
- 9610921
- FEI Number
- 3002806724
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CORNFORD RD.
- City
- BLACKPOOL, LANCASHIRE
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K043406
- PMA Number
- P960001
Owner / Operator
- Firm Name
- DePuy Synthes, Inc.
- Operator Number
- 1818910
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
US Agent
- Business Name
- DePuy Synthes
- Contact Name
- Patrick McCullagh
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
- [email protected]
- Phone
- 267 3005417
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2001-08-11 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2008-01-21 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2007-12-04 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-11-21 |
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2025-11-21 |
| Methyl Methacrylate For Aneurysmorrhaphy | JXH | Class 2 | Neurology | No | 2009-07-22 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2007-12-04 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2015-07-23 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2023-08-17 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2023-08-17 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2023-08-17 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2026-06-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2026-06-15 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2007-12-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-08-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-08-17 |
| Evacuator, Vapor, Cement Monomer | JDY | Class 1 | Orthopedic | No | 1978-03-27 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2025-11-21 |
Proprietary Names
MIXER
CEMENT
FOR CLINICAL USE (MULTIPLE BRANDS)
Vertebroplastic Radiopaque Bone Cement
Cemvac
Confidence High Viscosity Spinal Cement
SmartSet
Aneuroplastic
Bone Cement
Conduit TCP Granules
Rapid Resorb. Cranial Clamp
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
Orthomesh
Smartset (bone cement)
various cement dispensers
TELIGEN
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY
EVACUATOR
VAPOR
CEMENT MONOMER (MULTIPLE BRANDS)
VACU-MIX PUMP
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device