FDA Registration
Active
🇺🇸 United States
Rebar® Cervical Spacer System
Reg #: 3003855635
·
FEI: 3003855635
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ATLAS SPINE INC.
- Registration Number
- 3003855635
- FEI Number
- 3003855635
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1555 Jupiter Park Dr Ste 1
- City
- JUPITER
- State
- FL
- ZIP
- 33458
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063205
Owner / Operator
- Firm Name
- ATLAS SPINE INC.
- Operator Number
- 9053705
- Address
- 1555 JUPITER PARK DR., STE. 1, --
- City
- Jupiter
- State
- FL
- Postal Code
- 33458
- Country
- US
- Correspondent
- Thomas G Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2006-11-16 |
Proprietary Names
Rebar® Cervical Spacer System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device