FDA Registration
Active
🇿🇦 South Africa
VersaLat Ti 4.75mm Suture Anchor
Reg #: 3024856795
·
FEI: 3024856795
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORTHO-DESIGN
- Registration Number
- 3024856795
- FEI Number
- 3024856795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17 Dely Road, Hazelwood
- City
- Pretoria Gauteng
- Country
- ZA
Regulatory Submissions
- 510(k) Number
- K242296
Owner / Operator
- Firm Name
- Ortho-Design
- Operator Number
- 10086235
- Address
- 17 Dely Street
- City
- Pretoria
- State
- Gauteng
- Postal Code
- 0181
- Country
- ZA
- Correspondent
- Dian Peach
US Agent
- Business Name
- TriMed Inc.
- Contact Name
- David Medoff
- Address
- 27533 Avenue Hopkins, 3
- City
- Santa Clarita
- State
- CA
- ZIP
- 91355
- Country
- US
- [email protected]
- Phone
- 661 2557406
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-03-19 |
Proprietary Names
VersaLat Ti 4.75mm Suture Anchor
VersaLat PEEK 4.75mm Suture Anchor
VersaPEEK 4.5mm Suture Anchor
MicroTi Suture Anchor
VersaTap 5mm Suture Anchor
VersaPEEK 5.5mm Suture Anchor
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility