HTN
- Product code
- HTN
- Device name
- Washer, Bolt Nut
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 93
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253115 | 2026-06-10 | Movmedix S.A.S. | LARS ACJ | |
| K252081 | 2026-03-27 | Lincotek Medical | SportLinc Syndesmosis Device | |
| K253727 | 2025-12-22 | Arthrex, Inc. | Syndesmosis TightRope PRO | |
| K251643 | 2025-10-29 | Wright Medical Technology, Inc. (Stryk | Synchfix EVT | |
| K251134 | 2025-07-11 | TriMed, Inc. | RipCord | |
| K243624 | 2025-01-23 | Acumed, LLC | Acu-Sinch Knotless Mini | |
| K242091 | 2024-12-23 | Fusion Orthopedics | Bolo Button System | |
| K243408 | 2024-11-27 | Vilex, LLC | TACTIX Vector Syndesmosis System | |
| K242311 | 2024-11-01 | GM Dos Reis Industria e Comercio Ltda. | EXPERT - Flexible Joint Fixation System | |
| K240035 | 2024-08-01 | Vilex, LLC | TACTIX Vector Syndesmosis System | |
| K240947 | 2024-06-03 | Globus Medical, Inc. | TENSOR® Suture Button System | |
| K233531 | 2024-02-02 | Orthopaedic Implant Company | OIC FLEX-FIX System | |
| K232780 | 2023-12-18 | Cc-Instruments, Inc. | CC-Clip® Implant System | |
| K232755 | 2023-10-06 | Arthrex, Inc. | Arthrex FiberTape and TigerTape Cerclage Sutures |
Official FDA classification page: HTN
Classification and pathway per current FDA publications. Data from openFDA (CC0).