FDA Registration
Active
🇺🇸 United States
OSTEOTECH, INC.
Reg #: 2249915
·
FEI: 3002600221
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- OSTEOTECH, INC.
- Registration Number
- 2249915
- FEI Number
- 3002600221
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 201 Industrial Way West
- City
- EATONTOWN
- State
- NJ
- ZIP
- 07724
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061982
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- 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 | 2011-11-22 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2011-11-22 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-07-15 |
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2011-11-21 |
Proprietary Names
Plexur P
Grafton II eDBM
MagniFuse Bone Graft
MagniFuse
Graft Delivery Device with Integrated Stylet Syringe, Piston
Grafton DBM Plus
Grafton DBM Paste
Grafton DBM
Magnifuse II Bone Graft
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device