FDA Registration
Active
🇺🇸 United States
ALTUS PARTNERS
Reg #: 3009049161
·
FEI: 3009049161
·
Expires 2026
Products
10
Proprietary Names
17
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- ALTUS PARTNERS
- Registration Number
- 3009049161
- FEI Number
- 3009049161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1340 ENTERPRISE DR
- City
- WEST CHESTER
- State
- PA
- ZIP
- 19380
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200922
Owner / Operator
- Firm Name
- Altus Partners
- Operator Number
- 10035934
- Address
- 1340 Enterprise Drive
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
- Correspondent
- Michael Fitzgerald
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-12-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-12-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2020-06-04 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-12-31 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-11-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-01-06 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-01-06 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-01-06 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-12-27 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2021-12-02 |
Proprietary Names
Altus Spine HA Pedicle Screw System
Monaco Line Ext
Altus Spine Pedicle Screw System
Altus Spine Cervical Plate System
Indy Static Alif
Brickyard Static Alif
Altus Spine Navigation System
4.5 Fuji Screw
Altus Spine Cervical Interbody Fusion System
Intervertebral Fusion Device with bone graft, lumbar
Altus Spine Titanium Interbody Fusion System
Intervertebral fusion device with bone graft, lumbar
Altus Spine Interbody Standalone Fusion System
Brickyard Standalone
Indy Standalone
Monza Cervical Plate System
Altus Spine Sochi Oct Spinal System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device