FDA Registration
Active
🇫🇷 France
LDR MEDICAL
Reg #: 3004788213
·
FEI: 3004788213
·
Expires 2026
Products
37
Proprietary Names
0
Establishment Types
1
Classifications
37
Registration Details
- Registration Name
- LDR MEDICAL
- Registration Number
- 3004788213
- FEI Number
- 3004788213
- Status
- Active
- Expiry Year
- 2026
- 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
- K080572
- PMA Number
- P110009
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 | 2008-12-10 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-09-19 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-09-19 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-02-06 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2018-02-22 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2017-10-26 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2012-04-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2010-12-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2010-12-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2010-12-21 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-04-30 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Manual Instruments Designed For Use With Total Disc Replacement Devices | QLQ | Class 2 | Orthopedic | No | 2021-04-07 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-04-30 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2012-04-30 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2012-04-03 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2012-04-03 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2007-12-12 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2012-04-30 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-02-20 |
| Bender | HXW | Class 1 | Orthopedic | No | 2012-04-26 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2012-04-30 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2012-04-30 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2011-12-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2005-02-18 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2010-02-11 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2016-01-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-04-30 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2014-05-08 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility