HTN — Washer, Bolt Nut Class II
FDA product code HTN covers "Washer, Bolt Nut", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253115 | movmedix | LARS ACJ | June 10, 2026 |
| K252081 | lincotek medical | SportLinc Syndesmosis Device | March 27, 2026 |
| 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 |