FDA Registration
Active
🇺🇸 United States
ALLOSOURCE
Reg #: 3000215346
·
FEI: 3000215346
·
Expires 2026
Products
6
Proprietary Names
16
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ALLOSOURCE
- Registration Number
- 3000215346
- FEI Number
- 3000215346
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6278 S Troy Circle
- City
- Centennial
- State
- CO
- ZIP
- 80111
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103036
Owner / Operator
- Firm Name
- AlloSource
- Operator Number
- 10025681
- Address
- 6278 South Troy Circle
- City
- Centennial
- State
- CO
- Postal Code
- 80111
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2011-06-29 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2011-06-29 |
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | Class 2 | General, Plastic Surgery | No | 2017-12-19 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2023-12-11 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2022-07-15 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2018-07-03 |
Proprietary Names
AlloFuse Plus Paste
HERO DBM Plus Putty
HERO DBM Plus Paste
AlloFuse Plus Putty
StimuBlast CB Paste
StimuBlast CB Putty
BiomaX Bone Graft Putty Plus Chips
AlloFuse Gel
HERO DBM Putty
StimuBlast Putty
AlloFuse Putty
HERO DBM Gel
StimuBlast Gel
BiomaX Bone Graft Putty
ReConnex Pre-Sutured Tendon
AceConnex Pre-Sutured Fascia
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device