FDA Registration
Active
🇺🇸 United States
ACUITY SURGICAL DEVICES, LLC
Reg #: 3010866843
·
FEI: 3010866843
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ACUITY SURGICAL DEVICES, LLC
- Registration Number
- 3010866843
- FEI Number
- 3010866843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8710 N Royal Lane
- City
- Irving
- State
- TX
- ZIP
- 75063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143683
Owner / Operator
- Firm Name
- Acuity Surgical Devices, LLC
- Operator Number
- 10046711
- Address
- 8710 N Royal Lane
- City
- Irving
- State
- TX
- Postal Code
- 75063
- Country
- US
- Correspondent
- Bryan Cowan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-12-22 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-12-22 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-12-22 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-12-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-12-22 |
Establishment Types
Repack or Relabel Medical Device