FDA Registration
Active
🇫🇷 France
LDR MEDICAL
Reg #: 3004788213
·
FEI: 3004788213
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- LDR MEDICAL
- Registration Number
- 3004788213
- FEI Number
- 3004788213
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Parc dentreprises du Grande Troyes, Quartier Europe de lOuest, 5 rue de Berlin
- City
- Sainte-Savine Aube
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K121103
Owner / Operator
- Firm Name
- Highridge Medical, LLC
- Operator Number
- 9068198
- Address
- 10225 Westmoor Drive
- City
- Westminster
- State
- CO
- Postal Code
- 80021
- Country
- US
- Correspondent
- Alex Pawlowski
US Agent
- Business Name
- Highridge Medical
- Contact Name
- Elizabeth Ebmeier
- Address
- 10225 Westmoor Dr
- City
- Broomfield
- State
- CO
- ZIP
- 80021
- Country
- US
- [email protected]
- Phone
- 914 2919211
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2012-09-14 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2012-09-14 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-09-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-09-14 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2012-09-14 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2012-09-14 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2012-09-14 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-09-14 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-09-14 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility