FDA Registration
Active
🇺🇸 United States
SUMMIT TLSO
Reg #: 2030775
·
FEI: 3000206792
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ASPEN MEDICAL PRODUCTS, LLC
- Registration Number
- 2030775
- FEI Number
- 3000206792
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6481 OAK CANYON
- City
- IRVINE
- State
- CA
- ZIP
- 92618
- Country
- US
Owner / Operator
- Firm Name
- ASPEN MEDICAL PRODUCTS, LLC
- Operator Number
- 9027491
- Address
- 6481 OAK CANYON, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- JAMES CLOAR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 1997-05-23 |
Proprietary Names
SUMMIT TLSO
ASPEN CTO
CONTOUR TLSO
VISTA CTO
HORIZON TLSO
EVERGREEN TLSO
PEAK SCOLIOSIS BRACING SYSTEM
VISTA TLSO
ASPEN OTS 457 TLSO
ASPEN TLSO
Sierra TLSO
ASPEN TLSO 457
ASPEN SCOLIOSIS BRACING SYSTEM
Aspen Acute TLSO
Aspen Active P-TLSO
Sierra Hyperextension TLSO
Elite TLSO
ALIGN ORTHOSIS
VRTX CTLSO
VISTA II CTLSO
VRTX CTO
VRTX TLSO
FLX TLSO
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device