FDA Registration
Active
🇺🇸 United States
302015030 ORTHOPEDIC STEREOTAXIC INSTRUMENT
Reg #: 3009888740
·
FEI: 3009888740
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Orchid Orthopedic Solutions Alabama LLC
- Registration Number
- 3009888740
- FEI Number
- 3009888740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 331 City Park Dr SE
- City
- Arab
- State
- AL
- ZIP
- 35016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212756
Owner / Operator
- Firm Name
- Orchid Orhopedics
- Operator Number
- 10042268
- Address
- 331 City Park Dr. SE
- City
- Arab
- State
- AL
- Postal Code
- 35016
- Country
- US
- Correspondent
- Joel Roth
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-11-07 |
Proprietary Names
302015030 ORTHOPEDIC STEREOTAXIC INSTRUMENT
302015025 ORTHOPEDIC STEREOTAXIC INSTRUMENT
302015120 ORTHOPEDIC STEREOTAXIC INSTRUMENT
302015020 ORTHOPEDIC STEREOTAXIC INSTRUCMENT
302015100 ORTHOPEDIC STEREOTAXIC INSTRUMENT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)