FDA Registration
Active
🇺🇸 United States
Skeletal Dynamics Strategic Manufacturing Center
Reg #: 3026035863
·
FEI: 3026035863
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SKELETAL DYNAMICS STRATEGIC MANUFACTURING CENTER
- Registration Number
- 3026035863
- FEI Number
- 3026035863
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 28041 Trade Way Two, Unit 1
- City
- Bonita Springs
- State
- FL
- ZIP
- 34135
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200367
Owner / Operator
- Firm Name
- Skeletal Dynamics Strategic Manufacturing Center, LLC
- Operator Number
- 10087105
- Address
- 28041 Trade Way Two, Unit 1
- City
- Bonita Springs
- State
- FL
- Postal Code
- 34135
- Country
- US
- Correspondent
- Daniel C Ennis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-01-12 |
Proprietary Names
Skeletal Dynamics Strategic Manufacturing Center
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)