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 |
|---|
| K261651 | nuvasive specialized orthopedics | Precice Max System and Precice Ankle Salvage System | June 18, 2026 |
| K253080 | suzhou and science and technology development | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA0 | June 18, 2026 |
| K253155 | beijing fule science and technology development co | Fule Metallic Lockable Intramedullary Nail Systems | June 17, 2026 |
| K253046 | zhejiang decans medical devices co | HERA Interlocking Intramedullary Nailing System | June 16, 2026 |
| K260146 | orthofix | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | May 19, 2026 |
| K253991 | orthofix | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | May 8, 2026 |
| K261043 | globus medical | AUTOBAHN Nailing System | April 24, 2026 |
| K252016 | arthrex | Arthrex Humeral Nails | March 20, 2026 |
| K252961 | fusion orthopedics usa | Fusion FibFix Nail | March 18, 2026 |
| K253566 | zimmer | Affixus Retrograde Femoral Nailing System | March 12, 2026 |
| K253517 | reselute | Reselute Tibial Nail | March 10, 2026 |
| K252196 | arthrex | Arthrex FibuLock Nail System | March 5, 2026 |
| K253591 | paragon 28 | Phantom® Hindfoot TTC/TC 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 |