FDA Registration
Active
🇺🇸 United States
UNIVERSAL GRIPTION TF {TITANIUM FOAM} CONES (KNEES), GRIPTION TF ACETABULAR AUGMENT (HIP) SYSTEM [TRADITIONAL]
Reg #: 3008868758
·
FEI: 3008868758
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- EXEL INC. DBA DHL SUPPLY CHAIN (USA)
- Registration Number
- 3008868758
- FEI Number
- 3008868758
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9440 South State Road 39, Suite 200
- City
- Mooresville
- State
- IN
- ZIP
- 46158
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100391
Owner / Operator
- Firm Name
- Exel Inc. dba DHL Supply Chain (USA)
- Operator Number
- 10026656
- Address
- 360 Westar Blvd, Dept 555
- City
- Westerville
- State
- OH
- Postal Code
- 43082
- Country
- US
- Correspondent
- John Kropczynski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-11-23 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-11-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-11-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-11-23 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2021-11-23 |
Proprietary Names
UNIVERSAL GRIPTION TF {TITANIUM FOAM} CONES (KNEES), GRIPTION TF ACETABULAR AUGMENT (HIP) SYSTEM [TRADITIONAL]
Establishment Types
Repack or Relabel Medical Device