FDA Registration
Active
🇺🇸 United States
Allogenix
Reg #: 1032347
·
FEI: 1032347
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- BIOMET MICROFIXATION
- Registration Number
- 1032347
- FEI Number
- 1032347
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1520 Tradeport Dr
- City
- Jacksonville
- State
- FL
- ZIP
- 32218
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082793
Owner / Operator
- Firm Name
- BIOMET MICROFIXATION
- Operator Number
- 1032347
- Address
- 1520 TRADEPORT DR., --
- City
- Jacksonville
- State
- FL
- Postal Code
- 32218
- Country
- US
- Correspondent
- Jay M Sharma
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2022-04-04 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2022-04-04 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2022-04-04 |
Proprietary Names
Allogenix
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility