FDA Registration
Active
🇺🇸 United States
SPINAL TECHNOLOGY, LLC
Reg #: 1226318
·
FEI: 3002855566
·
Expires 2026
Products
7
Proprietary Names
23
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- SPINAL TECHNOLOGY, LLC
- Registration Number
- 1226318
- FEI Number
- 3002855566
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 191 MID TECH DR.
- City
- West Yarmouth
- State
- MA
- ZIP
- 02673
- Country
- US
Owner / Operator
- Firm Name
- Spinal Technology, LLC
- Operator Number
- 9039913
- Address
- 191 Mid Tech Drive, --
- City
- West Yarmouth
- State
- MA
- Postal Code
- 02673
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2019-12-11 |
| Monitor, Orthotic/Prosthetic | NHF | Class 1 | Physical Medicine | No | 2025-11-18 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2019-12-11 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2019-12-11 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2019-12-11 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2025-11-18 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1999-12-16 |
Proprietary Names
Providence Nocturnal Scoliosis Orthosis
Full-Time Scoliosis Orthosis
Pectus Brace
stWear® Compliance Monitor
LSO
SpinaLoc
Flex Foam 1
Flex Foam 3
Flex Foam 2
CTLSO
Scoliosis/Kyphosis Orthosis
Low Profile with Custom Sternal Shield
S.T.O.P. 1
TLSO
Milwaukee Orthosis
S.T.O.P. 4
Hip Orthosis
S.T.O.P. 3
S.T.O.P. 2
SpinaLoc 2
stWear® Portal
stWear® Smartphone App
SpinaLoc 2 - Ultra Low Profile Orthosis
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility