FDA Registration
Active
🇺🇸 United States
ACCUFIX SURGICAL, INC.
Reg #: 3020650900
·
FEI: 3020650900
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ACCUFIX SURGICAL, INC.
- Registration Number
- 3020650900
- FEI Number
- 3020650900
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3821 Beech St
- City
- Laramie
- State
- WY
- ZIP
- 82070
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200951
Owner / Operator
- Firm Name
- Accufix Surgical, Inc.
- Operator Number
- 10082818
- Address
- 385 Main Street, Suite 5
- City
- West Haven
- State
- CT
- Postal Code
- 06516
- Country
- US
- Correspondent
- John K Evans
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-09-12 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-09-12 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2021-10-06 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-09-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-09-12 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-09-12 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2022-09-12 |
Proprietary Names
Accu-Joint Hemi Implant Instrument Kit
Accu-Joint Hemi Implant
Accu-joint Hemi Implant Single Sterile
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility