FDA Registration
Active
🇺🇸 United States
APTIS MEDICAL, LLC.
Reg #: 3004521401
·
FEI: 3004521401
·
Expires 2026
Products
10
Proprietary Names
0
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- APTIS MEDICAL, LLC.
- Registration Number
- 3004521401
- FEI Number
- 3004521401
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3602 Glenview Ave
- City
- Glenview
- State
- KY
- ZIP
- 40025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040497
Owner / Operator
- Firm Name
- APTIS MEDICAL, LLC.
- Operator Number
- 9054354
- Address
- 3602 Glenview Ave., --
- City
- Glenview
- State
- KY
- Postal Code
- 40025
- Country
- US
- Correspondent
- Barbara A Chesher
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | Class 2 | Orthopedic | No | 2018-06-27 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2009-05-27 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-08-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2009-05-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2009-05-27 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2009-05-27 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2009-05-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-06-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2009-05-27 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2009-05-27 |
Establishment Types
Manufacture Medical Device