Pro-X1? Trochanteric Nailing System
X-Bolt Orthopedics
X-BOLT ORTHOPEDICS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010368646 | 3010368646 | X-BOLT ORTHOPEDICS | 1 | N | 2026-01-01 | Unit 5 Northwood Court Santry Dublin(County) IE D09AX54 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 306065 | 1373470996 | K221621 | Pro-X1™ Trochanteric Nailing System | HSB | 2023-03-06 |
| 306065 | 1652897917 | K181640 | X-BOLT Hip Fracture Fixation System | HSB | 2018-10-12 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HSB | 2 | 2023-03-06 |