FDA Registration
Active
🇺🇸 United States
OSTEOGENICS BIOMEDICAL, INC.
Reg #: 1650372
·
FEI: 3002253367
·
Expires 2026
Products
11
Proprietary Names
21
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- OSTEOGENICS BIOMEDICAL, INC.
- Registration Number
- 1650372
- FEI Number
- 3002253367
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4620 71st St Bldg 78-79
- City
- LUBBOCK
- State
- TX
- ZIP
- 79424
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201187
Owner / Operator
- Firm Name
- OSTEOGENICS BIOMEDICAL, INC.
- Operator Number
- 9028315
- Address
- 4620 71ST ST., BLDG. 78-79, --
- City
- Lubbock
- State
- TX
- Postal Code
- 79424
- Country
- US
- Correspondent
- Salem O'Steen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-08-28 |
| Barrier, Synthetic, Intraoral | NPK | Class 2 | Dental | No | 2022-03-23 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2011-06-06 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2023-01-19 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2016-12-21 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2007-12-14 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2009-03-02 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2020-12-02 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2016-12-21 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2007-12-14 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2017-07-11 |
Proprietary Names
Pro-fix 56 mm Cruciform Driver Blade
Pro-Fix Contra Angle Driver Blade
Pro-fix 76 mm Cruciform Driver Blade
Pro-fix Bone Fixation Screws
Pro-fix Membrane Fixation Screws
Pro-fix Tenting Screws
Pro-fix Precision Fixation System
Symbios Collagen Membrane
Cytoplast RTM Collagen Membrane
Pro-fix Tecapro Storage Tray
Osteo-Mesh TM-300 Titanium Mesh
Vitala
Cytoplast PTFE Sutures
RTM Dental Wound Dressings
RPM Reinforced PTFE Mesh
Pro-fix Driver Handle
Cytoplast GBR/TXT d-PTFE Membranes
Cytoplast Titanium-Reinforced PTFE Membranes
ZCORE porcine xenograft particulate IN SYRINGE
Zcore Porcine Xenograft Particulate
ZCORE EXPAND Expandable Collagen-Enriched Porcine Xenograft
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)