FDA Registration
Active
🇺🇸 United States
KAPSTONE MANUFACTURING
Reg #: 3016248538
·
FEI: 3016248538
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- KAPSTONE MANUFACTURING
- Registration Number
- 3016248538
- FEI Number
- 3016248538
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 520 Elliot St
- City
- Charlotte
- State
- NC
- ZIP
- 28202
- Country
- US
Owner / Operator
- Firm Name
- Kapstone Manufacturing
- Operator Number
- 10062247
- Address
- 520 Elliot St
- City
- Charlotte
- State
- NC
- Postal Code
- 28202
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-05-22 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2026-06-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-05-22 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-12-13 |
Proprietary Names
ExoToe
Suture Shield
Pathfinder ACL System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)