FDA Registration
Active
🇧🇷 Brazil
OSTEOMED IMPLANTES
Reg #: 3023138345
·
FEI: 3023138345
·
Expires 2026
Products
7
Proprietary Names
4
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- OSTEOMED IMPLANTES
- Registration Number
- 3023138345
- FEI Number
- 3023138345
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rod Washington Luis km 172, pista sul - cond. ind.conpark
- City
- Rio Claro Sao Paulo
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K143572
Owner / Operator
- Firm Name
- Osteomed Implantes
- Operator Number
- 10085391
- Address
- Rod Washington Luis km 172, pista sul - cond. ind.conpark
- City
- Rio Claro
- State
- Sao Paulo
- Postal Code
- 13500970
- Country
- BR
- Correspondent
- Fernando Argenton Neto
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-06-13 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-06-13 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-12-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-12-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2022-06-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2022-06-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-06-13 |
Proprietary Names
Intervertebral body fusion device (Cage's PEEK)
Mini-OSTEO Pedicle Fixation System
Pedicle screw spinal system (DPZ)
Spinal intervertebral body fixation orthosis Anterior Cervical Plate System.
Establishment Types
Manufacture Medical Device