FDA Registration
Active
🇺🇸 United States
UNITED SURGICAL LLC
Reg #: 2087423
·
FEI: 3003707831
·
Expires 2026
Products
9
Proprietary Names
5
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- UNITED SURGICAL LLC
- Registration Number
- 2087423
- FEI Number
- 3003707831
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11654 E 400 S
- City
- Laotto
- State
- IN
- ZIP
- 46763
- Country
- US
Owner / Operator
- Firm Name
- UNITED SURGICAL INC dba UNITED ORTHO
- Operator Number
- 9052541
- Address
- 2235 Pennsylvania St, --
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46803
- Country
- US
- Correspondent
- Andrew M Opliger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crutch | IPR | Class 1 | Physical Medicine | No | 2024-09-23 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2014-02-07 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2025-09-05 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2015-03-31 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2014-06-10 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2015-03-31 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2015-03-31 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2015-03-31 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2015-03-31 |
Proprietary Names
Aluminum Crutches
FKB ACL Knee Brace
Abdominal Binder
Walking Boot
Sling Arm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device