Sprout3D - Cranial Remolding Orthosis
2025-02-03
SURESTEP, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003895329 | 3003895329 | SURESTEP, LLC | 1 | N | 2026-01-01 | 17530 DUGDALE DR South Bend IN US 46635 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 97846 | 1221644290 | K203134 | Hanger Cranial Band 3D | MVA | 2022-07-01 |
| 97846 | 1311016701 | ||||
| 97846 | 1412561704 | ||||
| 97846 | 1485896485 | ||||
| 97846 | 1635790222 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MVA | 1 | 2022-07-01 |