Product code HSB
- Device name
- Rod, Fixation, Intramedullary And Accessories
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3020
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261189 | Freedom Nail Ankle Fusion System | McGinley Orthopaedic Innovations | 2026-10-19 |
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026-09-24 |
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026-06-29 |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | 2026-06-18 |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026-06-18 |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | 2026-05-19 |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026-05-08 |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026-04-24 |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026-03-20 |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026-03-18 |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026-03-12 |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026-03-10 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026-03-05 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026-03-04 |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026-02-03 |
| K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | 2025-12-12 |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 2025-12-10 |
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 2025-10-17 |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | 2025-09-12 |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | 2025-08-20 |
| K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025-08-13 |
| K250622 | Succession™ AFN System | Ortho Solutions UK , Ltd. | 2025-08-07 |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025-07-14 |
| K250559 | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | 2025-06-12 |
| K242247 | ARIX Femur Nail System | Jeil Medical Corporation | 2025-04-22 |
| K250112 | FitboneTM Trochanteric | Orthofix Srl | 2025-04-10 |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840194462730 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2023-09-15 |
| 00840194462693 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2023-09-15 |
| 00840194462686 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2023-09-15 |
| 00840194462594 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2023-09-15 |
| 00840194462587 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2023-09-15 |
| 00840194445993 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2023-09-15 |
| 00840194445986 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2023-09-15 |
| 00840194405997 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194417334 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194417327 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194417310 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194417297 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194405980 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194406000 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194407687 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194407700 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194407717 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194407724 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194407748 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194417280 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00840194417303 | Pediatric Nailing Platform Femur | ORTHOPEDIATRICS CORP. | 2022-09-16 |
| 00841132139936 | Pediatric Nailing Platform|Femur | ORTHOPEDIATRICS CORP. | 2020-02-27 |
| 00841132150443 | PediNail Intramedullary Platform | ORTHOPEDIATRICS CORP. | 2018-05-31 |
| 00841132150450 | PediNail Intramedullary Platform | ORTHOPEDIATRICS CORP. | 2018-05-31 |
| 00841132150467 | PediNail Intramedullary Platform | ORTHOPEDIATRICS CORP. | 2018-05-31 |
| 00841132150474 | Pediatric Nailing Platform | Tibia | ORTHOPEDIATRICS CORP. | 2018-05-31 |
| 00841132150481 | PediNail Intramedullary Platform | ORTHOPEDIATRICS CORP. | 2018-05-31 |
| 00841132150498 | PediNail Intramedullary Platform | ORTHOPEDIATRICS CORP. | 2018-05-31 |
| 00841132150504 | PediNail Intramedullary Platform | ORTHOPEDIATRICS CORP. | 2018-05-31 |
| 00841132150511 | PediNail Intramedullary Platform | ORTHOPEDIATRICS CORP. | 2018-05-31 |