JDR — Staple, Fixation, Bone Class II
FDA Device Classification
Classification Details
- Product Code
- JDR
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250712 | trax surgical | Linkt Compression Staple System | May 14, 2025 |
| K243888 | medline industries | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | April 11, 2025 |
| K243742 | arthrex | Arthrex DynaNite Nitinol Staples | January 31, 2025 |
| K243658 | treace medical concepts | TMC Compression Implant System | December 26, 2024 |
| K242415 | treace medical concepts | TMC Compression Implant System | September 6, 2024 |
| K240212 | ortho solutions uk | COGNiTiON Staple System | February 23, 2024 |
| K232990 | rmr ortho | ATOMIC Nitinol Fixation System | January 12, 2024 |
| K230724 | novastep | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | December 4, 2023 |
| K232905 | medline industries | Medline UNITE® REFLEX® Nitinol Staple Kit | October 19, 2023 |
| K232324 | medartis | StealthFix Intraosseous Fixation System | August 30, 2023 |
| K232387 | treace medical concepts | Treace Medical Concepts (TMC) Compression Implant System | August 28, 2023 |
| K231493 | vilex | NITINEX Memory Compression Staple | August 11, 2023 |
| K231885 | medline industries | Medline UNITE® REFLEX® Nitinol Staple System | August 9, 2023 |
| K231458 | restor3d | Extremity Staple | August 3, 2023 |
| K230550 | paragon 28 | JAWS Nitinol Staple System | May 11, 2023 |
| K223056 | paragon 28 | JAWS Nitinol Staple System | February 16, 2023 |
| K222645 | treace medical concepts | Treace Medical Concepts (TMC) Implant Fixation System | November 21, 2022 |
| K221947 | tyber medical | Tyber Medical Staple Fixation System (various) | October 20, 2022 |
| K220812 | medshape | DynaClip® Bone Staple | August 19, 2022 |
| K210582 | stryker | EasyClip® and EasyClip® Xpress | June 10, 2022 |