HTN — Washer, Bolt Nut Class II
FDA Device Classification
Classification Details
- Product Code
- HTN
- 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 |
|---|
| K253727 | arthrex | Syndesmosis TightRope PRO | December 22, 2025 |
| K251643 | wright medical technology, inc. (stryker corporation) | Synchfix EVT | October 29, 2025 |
| K251134 | trimed | RipCord | July 11, 2025 |
| K243624 | acumed | Acu-Sinch Knotless Mini | January 23, 2025 |
| K242091 | fusion orthopedics | Bolo Button System | December 23, 2024 |
| K243408 | vilex | TACTIX Vector Syndesmosis System | November 27, 2024 |
| K242311 | gm dos reis industria e comercio ltda | EXPERT - Flexible Joint Fixation System | November 1, 2024 |
| K240035 | vilex | TACTIX Vector Syndesmosis System | August 1, 2024 |
| K240947 | globus medical | TENSOR® Suture Button System | June 3, 2024 |
| K233531 | orthopaedic implant | OIC FLEX-FIX System | February 2, 2024 |
| K232780 | cc-instruments | CC-Clip® Implant System | December 18, 2023 |
| K232755 | arthrex | Arthrex FiberTape and TigerTape Cerclage Sutures | October 6, 2023 |
| K221485 | arthrex | Arthrex FiberTape and TigerTape Cerclage Sutures | August 22, 2022 |
| K220947 | arthrex | Arthrex Knotless AC Repair Devices | June 6, 2022 |
| K220650 | trimed | TriMed Ripcord Device | June 1, 2022 |
| K220260 | in2bones usa | Hercules Syndesmosis Implant System | March 31, 2022 |
| K212990 | acumed | Acumed Ankle Syndesmosis Repair System | January 7, 2022 |
| K213644 | arthrex | Arthrex Knotless Mini TightRopes | December 17, 2021 |
| K211612 | medline industries | Medline UNITE REFLEX Dynamic Discs | December 10, 2021 |
| K200332 | gm dos reis industria e comercio ltda | EXPERT - Joint Fixation System | October 29, 2020 |