FDA Registration
Active
🇺🇸 United States
LIFENET HEALTH
Reg #: 3005064037
·
FEI: 3005064037
·
Expires 2026
Products
10
Proprietary Names
16
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- LIFENET HEALTH
- Registration Number
- 3005064037
- FEI Number
- 3005064037
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1864 CONCERT DR.
- City
- Virginia Beach
- State
- VA
- ZIP
- 23453
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201338
Owner / Operator
- Firm Name
- LIFENET HEALTH
- Operator Number
- 9079121
- Address
- 1864 CONCERT DR., --
- City
- VIRGINIA BEACH
- State
- VA
- Postal Code
- 23453
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2007-08-27 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-04-08 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2024-12-16 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2024-12-16 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2008-12-10 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Filler, Bone Void, Non-Osteoinduction | MBS | Class 3 | Unknown | No | 2013-01-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-09-24 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2024-09-24 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-09-24 |
Proprietary Names
FlexiGRAFT GraftLink
FlexiGRAFT Sutured Lateral Ankle Tendon Construct
FlexiGRAFT GraftLink TS
FlexiGRAFT Connect EXT
FlexiGRAFT Connect
FlexiGRAFT QuadLink
FlexiGRAFT DualLink
Allograft MIS Delivery System
ViviGen MIS Delivery System
PliaFX Flo
CardioGRAFT-MC Decellularized Pulmonary Artery Patch
Optium DBM
Vesuvius DBM Putty
I/C Graft Chamber
ReadiGraft BLX DBM & CC PUTTY
ReadiGraft BLX DBM Putty
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Manufacture Device in the United States for Export Only