ORTHO-DESIGN
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3024856795 | 3024856795 | ORTHO-DESIGN | 1 | N | 2026-01-01 | 61 Thomas Edison Menly Park Pretoria Gauteng ZA 0081 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 310123 | 1267110510 | K242296 | VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) | MBI | 2024-08-29 |
| 310123 | 1484301009 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | MBI | 2021-12-06 |
| 310123 | 1444343202 | ||||
| 310123 | 1696610174 | ||||
| 310123 | 1765276712 | ||||
| 310123 | 1967747558 | ||||
| 310123 | 2062313422 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MBI | 2 | 2024-08-29 |