FDA Registration
Active
🇺🇸 United States
SKY SURGICAL
Reg #: 3030691054
·
FEI: 3030691054
·
Expires 2026
Products
7
Proprietary Names
1
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- SKY SURGICAL
- Registration Number
- 3030691054
- FEI Number
- 3030691054
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8600 NW 64th Street, #203
- City
- Parkville
- State
- MO
- ZIP
- 64152
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233154
Owner / Operator
- Firm Name
- Sky Surgical
- Operator Number
- 10090370
- Address
- 8600 NW 64th Street, #203
- City
- Parkville
- State
- MO
- Postal Code
- 64152
- Country
- US
- Correspondent
- Jeff Sander
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2024-03-26 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-03-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-03-26 |
| Template | HWT | Class 1 | Orthopedic | No | 2024-03-26 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2024-03-26 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-03-26 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2024-03-26 |
Proprietary Names
SkyOPS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198