FDA Registration
Active
🇺🇸 United States
Zimmer Segmental System
Reg #: 3005751028
·
FEI: 3005751028
·
Expires 2025
Products
3
Proprietary Names
6
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Zimmer Trabecular Metal Technology, Inc.
- Registration Number
- 3005751028
- FEI Number
- 3005751028
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10 POMEROY RD.
- City
- Parsippany
- State
- NJ
- ZIP
- 07054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070978
Owner / Operator
- Firm Name
- ZIMMER, INC.
- Operator Number
- 1822565
- Address
- 345 E. Main Street, --
- City
- Warsaw
- State
- IN
- Postal Code
- 46580
- 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 | 2007-11-08 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2007-11-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2007-11-08 |
Proprietary Names
Zimmer Segmental System
Zimmer Segmental System, Trabecular Metal Stem Collar, 35mm O.D., 00-5852-040-35
Zimmer Segmental System, Trabecular Metal Stem Collar, 30mm O.D., 00-5852-040-30
Zimmer Segmental System, Trabecular Metal Stem Collar, 30mm O.D., 00-5852-041-30
Zimmer Segmental System, Trabecular Metal Stem Collar, 25mm O.D., 00-5852-040-25
Zimmer Segmental System, Trabecular Metal Stem Collar, 35mm O.D., 00-5852-041-35
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)