HSB — Rod, Fixation, Intramedullary And Accessories Class II
FDA Device Classification
Classification Details
- Product Code
- HSB
- Device Class
- Class II
- Regulation Number
- 888.3020
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253566 | zimmer | Affixus Retrograde Femoral Nailing System | March 12, 2026 |
| K253517 | reselute | Reselute Tibial Nail | March 10, 2026 |
| K253591 | paragon 28 | Phantom® Hindfoot TTC/TC Nail System | March 5, 2026 |
| K252196 | arthrex | Arthrex FibuLock Nail System | March 5, 2026 |
| K252025 | satori orthopaedics | Active Intramedullary (AIM) Tibial Nail System | March 4, 2026 |
| K253640 | stryker | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | February 3, 2026 |
| K253749 | zimmer switzerland manufacturing | Affixus® Natural Nail® Proximal Humeral System | December 12, 2025 |
| K252826 | jeil medical corporation | ARIX Femur Nail System | December 10, 2025 |
| K250197 | citieffe | Estremo Fibular Nail | October 17, 2025 |
| K250628 | medshape | DynaNail TTC Fusion System | September 12, 2025 |
| K251400 | stryker | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | August 20, 2025 |
| K250163 | stryker | T2 Alpha Femur Retrograde Nailing System | August 13, 2025 |
| K250622 | ortho solutions uk | Succession AFN System | August 7, 2025 |
| K251850 | paragon 28 | Phantom® Hindfoot TTC/TC Nail System | July 14, 2025 |
| K250559 | gm dos reis industria e comercio | GMReis Fibula Nail System | June 12, 2025 |
| K242247 | jeil medical corporation | ARIX Femur Nail System | April 22, 2025 |
| K250112 | orthofix | FitboneTM Trochanteric | April 10, 2025 |
| K250623 | orthopediatrics | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | April 1, 2025 |
| K241983 | orthopediatrics canada ulc dba pega medical | Fassier-Duval Telescoping IM System | February 21, 2025 |
| K243907 | zimmer | Affixus Tibial Nailing System - 4mm screws | February 12, 2025 |