KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class II
FDA Device Classification
Classification Details
- Product Code
- KTT
- 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 |
|---|
| K253291 | blue ocean global | Excelsior System | January 20, 2026 |
| K253613 | paragon 28 | Monkey Rings External Ring Fixation System | December 19, 2025 |
| K253202 | stryker | Hoffmann LRF System | December 19, 2025 |
| K252555 | medusa orthopedics | Medusa Orthopedics Boa External Fixation System | November 25, 2025 |
| K252625 | response ortho solutions | The Response Ortho Smart Fixator - Hexapod System | November 20, 2025 |
| K252106 | paragon 28 | External Fixation Mini Rail System | September 30, 2025 |
| K251862 | paragon 28 | External Fixation Bone Distractor | August 11, 2025 |
| K250472 | amdt holdings | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | August 8, 2025 |
| K251128 | extremity medical | Extremity Medical External Fixation System | May 7, 2025 |
| K243798 | orthopediatrics | Orthex External Fixation System | March 7, 2025 |
| K241563 | extremity medical | Extremity Medical External Fixation System | February 21, 2025 |
| K242861 | orthofix | TrueLok Elevate | December 3, 2024 |
| K242452 | paragon 28 | Monkey Bars Pin to Bar External Fixation System | November 1, 2024 |
| K241769 | response ortho solutions | Response Ortho Metaphyseal Hinge Fixator System | September 18, 2024 |
| K233025 | new standard device dba metalogix | Revolution External Plating System | May 30, 2024 |
| K240049 | metric medical devices | LINK(TM) External Fixator | May 29, 2024 |
| K233741 | stryker | Hoffmann LRF System | December 21, 2023 |
| K221787 | auxein medical private limited | Auxein's DHS/DCS Plate System | November 30, 2023 |
| K232897 | arthrex | Arthrex Small External Fixation System | October 18, 2023 |
| K232838 | paragon 28 | Monkey RingsTM External Fixation System | October 12, 2023 |