FDA Registration
Active
🇺🇸 United States
Elite Medical, LLC
Reg #: 3017565094
·
FEI: 3017565094
·
Expires 2026
Products
37
Proprietary Names
0
Establishment Types
1
Classifications
37
Registration Details
- Registration Name
- Elite Medical, LLC
- Registration Number
- 3017565094
- FEI Number
- 3017565094
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4001 Helton Drive
- City
- Florence
- State
- AL
- ZIP
- 35630
- Country
- US
Owner / Operator
- Firm Name
- Elite Medical, LLC
- Operator Number
- 10042156
- Address
- 8415 Wolf Lake Drive
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2024-04-04 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2018-12-20 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-25 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-12-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-12-09 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-11-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-10-25 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2014-12-29 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-01-25 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-01-25 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-25 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2013-01-18 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-12-31 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2015-05-11 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-18 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-12-09 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-12-09 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2019-12-09 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-01-18 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-18 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-18 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-01-12 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-25 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-01-12 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-18 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2024-01-08 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-25 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-18 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-01-18 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-18 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2013-01-25 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2019-12-09 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-18 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-01-25 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2015-04-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2014-12-29 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)