FDA Registration
Active
🇺🇸 United States
ProMed Concepts, LLC
Reg #: 3010123303
·
FEI: 3010123303
·
Expires 2026
Products
26
Proprietary Names
26
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- ProMed Concepts, LLC
- Registration Number
- 3010123303
- FEI Number
- 3010123303
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7203 Hwy 14
- City
- Brighton
- State
- TN
- ZIP
- 38011
- Country
- US
Owner / Operator
- Firm Name
- ProMed Concepts, LLC
- Operator Number
- 10043266
- Address
- 7203 Hwy 14
- City
- Brighton
- State
- TN
- Postal Code
- 38011
- Country
- US
- Correspondent
- Carolyn M Morrison
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-02-01 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-02-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-01 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-02-01 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-02-01 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-02-01 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-02-01 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-02-01 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-01 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-02-01 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-02-01 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2013-02-01 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2013-02-01 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2013-02-01 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-02-01 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-02-01 |
Proprietary Names
TREPHINE
IMPACTOR
ORTHOPEDIC, MANUAL, SURGICAL, INSTRUMENT
TAP,BONE
SPINAL, VERTABRAL BODY REPLACEMENT DEVICE
MALLET, SURGICAL, GENERAL AND PLASTIC SURGERY
CURETTE
TEMPLATE
BENDER
RASP
RETRACTOR
BLADE, SCALPEL
PROBE
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
SCREWDRIVER
AWL
REAMER
STARTER, BONE SCREW
KNIFE SURGICAL
INSTRUMENT, SURGICAL, ORTHOPEDIC AC POWERED MOTOR AN ACCESSORY ATTACHMENT
OSTEOTOME
CRIMPER, PIN
GUIDE, SURGICAL, INSTRUMENT
RONGEUR
TAMP
INVERTABRAL FUSION DEVICE WITH BONE GRAFT CERVICAL
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)