FDA Registration
Active
🇺🇸 United States
FlexiGRAFT GraftLink
Reg #: 3009672666
·
FEI: 3009672666
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LifeNet Health Northwest
- Registration Number
- 3009672666
- FEI Number
- 3009672666
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 501 Sw 39th St
- City
- Renton
- State
- WA
- ZIP
- 98057
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041553
Owner / Operator
- Firm Name
- LIFENET HEALTH
- Operator Number
- 9079121
- Address
- 1864 CONCERT DR., --
- City
- VIRGINIA BEACH
- State
- VA
- Postal Code
- 23453
- Country
- US
- Correspondent
- MICHAEL A PLEW
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 |
Proprietary Names
FlexiGRAFT GraftLink
FlexiGRAFT Sutured Lateral Ankle Tendon Construct
FlexiGRAFT Connect
FlexiGRAFT QuadLink
FlexiGRAFT Connect EXT
FlexiGRAFT GraftLink TS
FlexiGRAFT DualLink
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)