FDA Registration
Active
🇿🇦 South Africa
SOUTHERN MEDICAL (PTY) LTD
Reg #: 3003898943
·
FEI: 3003898943
·
Expires 2026
Products
11
Proprietary Names
8
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- SOUTHERN MEDICAL (PTY) LTD
- Registration Number
- 3003898943
- FEI Number
- 3003898943
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 55 Regency, Route 21 Corporate Park, Irene, Pretoria
- City
- IRENE Gauteng
- Country
- ZA
Regulatory Submissions
- 510(k) Number
- K231145
Owner / Operator
- Firm Name
- Southern Medical (Pty) Ltd
- Operator Number
- 9052759
- Address
- 55 Regency, Route 21 Corporate Park, Irene, --
- City
- Pretoria
- State
- Gauteng
- Postal Code
- 0062
- Country
- ZA
- Correspondent
- Dalene - Styger
US Agent
- Business Name
- Southern Implants North America Inc.
- Contact Name
- David Luiz
- Address
- 225 Chimney Corner Lane, Suite 3011
- City
- Jupiter
- State
- FL
- ZIP
- 33458
- Country
- US
- [email protected]
- Phone
- 561 4720990 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-09-05 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-01-11 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-12-18 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-09-05 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2023-02-15 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2023-09-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-10-14 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2023-12-18 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2026-01-06 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2026-01-06 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-01-11 |
Proprietary Names
Axis
Southern SASCA
Riven Caspar Distractor
SPICCA
SPICCA-SP
Riven Caspar Pins
Southern Maxillofacial (MF) system
Southern TLIF
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device