FDA Registration
Active
🇺🇸 United States
HOOSIER, INC.
Reg #: 2032093
·
FEI: 3003058119
·
Expires 2026
Products
15
Proprietary Names
20
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- HOOSIER, INC.
- Registration Number
- 2032093
- FEI Number
- 3003058119
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1140 California Ave
- City
- Corona
- State
- CA
- ZIP
- 92881
- Country
- US
Owner / Operator
- Firm Name
- HOOSIER, INC.
- Operator Number
- 9041670
- Address
- 1140 California Ave, --
- City
- Corona
- State
- CA
- Postal Code
- 92881
- Country
- US
- Correspondent
- Mitchell - McCall
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-01-17 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2014-10-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-10 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-10-27 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-01-10 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2014-10-27 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-10 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-01-10 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2013-03-01 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-01-10 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-10-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-10-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-10-27 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-10-27 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-10-27 |
Proprietary Names
SJF
IFDIFC
OMSI
OVEIFDIFC2
AFSIB
KWQAFSIB3
JDQCF
SCRDRI
MQPSVBRD2
KWQAFSIB2
MAXIFDBGL
PKPFSCUPCPP
OVDMQP2
AFSIOSPF
AFSI
SVBRD
IFDBGC
MAXODPMQP
KWQAFSIB1
MNIOSPF
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)