FDA Registration
Active
🇺🇸 United States
Genesis All Suture Anchor
Reg #: 3016948539
·
FEI: 3008066433
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENESIS BIOLOGICS, INC.
- Registration Number
- 3016948539
- FEI Number
- 3008066433
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 17791 Mitchell North, Suite D
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222423
Owner / Operator
- Firm Name
- Genesis Biologics, Inc.
- Operator Number
- 10074842
- Address
- 17791 Mitchell North, Suite D
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
- Correspondent
- Steven Bee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-01-19 |
Proprietary Names
Genesis All Suture Anchor
Establishment Types
Complaint File Establishment per 21 CFR 820.198