FDA Registration
Active
🇺🇸 United States
Longevity IT Highly Crosslinked Polyethylene Oblique Liners
Reg #: 2244478
·
FEI: 1000136269
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Cosmed Group, Inc., d/b/a Cosmed of NJ
- Registration Number
- 2244478
- FEI Number
- 1000136269
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19 PARK DR.
- City
- Franklin
- State
- NJ
- ZIP
- 07416
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123019
Owner / Operator
- Firm Name
- Cosmed Group, Inc.
- Operator Number
- 2244478
- Address
- 28 Narragansett Ave.
- City
- Jamestown
- State
- RI
- Postal Code
- 02835
- 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 | 2022-12-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-12-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-12-20 |
Proprietary Names
Longevity IT Highly Crosslinked Polyethylene Oblique Liners
Longevity IT Highly Crosslinked Polyethylene Neutral Liners
Longevity IT Highly Crosslinked Polyethylene Elevated Liners
Longevity IT Highly Crosslinked Polyethylene Offset Liners
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)