FDA Registration
Active
🇺🇸 United States
Sites Medical, LLC
Reg #: 3009923578
·
FEI: 3009923578
·
Expires 2026
Products
12
Proprietary Names
16
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Sites Medical, LLC
- Registration Number
- 3009923578
- FEI Number
- 3009923578
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4707 E Park 30 Drive
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Owner / Operator
- Firm Name
- Sites Medical, LLC
- Operator Number
- 10042319
- Address
- 4707 E Park 30 Drive
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
- Correspondent
- Steve Leins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2025-12-08 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-01-14 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2018-10-22 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2018-10-22 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-10-22 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2025-01-14 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2025-01-14 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-12-22 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2015-12-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-12-22 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-01-14 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-01-14 |
Proprietary Names
HSN - PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Universe Reverse
Spinal Jaxx
Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology
ATEC Spacer
InTice-C
Evolution Tibial Cones
Great Toe Hemiarthroplasty Implant
Wedge
Forticore
Agility
iBalance
Arthrex univers Revers Modular Glenoid System
Anatomic PEEK Cervical Fusion System with Nanotechnology
Titanium Interbody System
Lesser Toe Hemiarthroplasty Implant
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)