FDA Registration
Active
🇺🇸 United States
A400 Tapered Cementless Hip System
Reg #: 3011660613
·
FEI: 3011660613
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- 3D Medical Manufacturing, Inc.
- Registration Number
- 3011660613
- FEI Number
- 3011660613
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7145 Colonial Lane
- City
- Pennsauken
- State
- NJ
- ZIP
- 08109
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112897
Owner / Operator
- Firm Name
- 3D Medical Manufacturing, inc. DBA Tecomet
- Operator Number
- 10043250
- Address
- 2001 Congress Avenue
- City
- Riviera Beach
- State
- FL
- Postal Code
- 33404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-01-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-01-07 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2025-01-07 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-01-07 |
Proprietary Names
A400 Tapered Cementless Hip System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)