Product code HTN
- Device name
- Washer, Bolt Nut
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | 2026-03-27 |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 2025-12-22 |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 |
| K251134 | RipCord | TriMed, Inc. | 2025-07-11 |
| K243624 | Acu-Sinch Knotless Mini | Acumed, LLC | 2025-01-23 |
| K242091 | Bolo Button System | Fusion Orthopedics | 2024-12-23 |
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-11-27 |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 |
| K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-08-01 |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | 2024-06-03 |
| K233531 | OIC FLEX-FIX™ System | Orthopaedic Implant Company | 2024-02-02 |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | 2023-12-18 |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023-10-06 |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022-08-22 |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex, Inc. | 2022-06-06 |
| K220650 | TriMed Ripcord Device | TriMed, Inc. | 2022-06-01 |
| K220260 | Hercules Syndesmosis Implant System | In2bones USA, LLC | 2022-03-31 |
| K212990 | Acumed Ankle Syndesmosis Repair System | Acumed, LLC | 2022-01-07 |
| K213644 | Arthrex Knotless Mini TightRopes | Arthrex, Inc. | 2021-12-17 |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Medline Industries, Inc. | 2021-12-10 |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020-10-29 |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | Arthrex, Inc. | 2020-09-03 |
| K200361 | Akros Scruture Anchor LisFranc Repair Kit | Akros Medical | 2020-04-06 |
| K190143 | LARS AC Band Device | Corin USA | 2019-11-04 |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | Conmed Corporation | 2019-06-28 |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | Conmed Corporation | 2019-06-28 |
| K183094 | CyclaPlex Correction System | Cycla Orthopedics, Ltd. | 2019-04-26 |
| K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019-03-12 |
| K180243 | Infinity-Lock Button System | Xiros, Ltd. | 2018-04-03 |
| K171703 | PUMA System | Panther Orthopedics, Inc. | 2018-03-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850080543085 | PC Fix Thoracic Plate 95mm PEEK | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543061 | PC Fix Intrathoracic Plate 95mm Ti | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543054 | PC Fix Intrathoracic Plate 70mm Ti | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543047 | PC Fix Extrathoracic Plate 95mm Ti | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543030 | PC Fix Extrathoracic Plate 70mm Ti | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543023 | PC Fix Washer Ti | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543016 | PC Fix Locking Cap Ti | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543009 | PC Fix Locking Post Ti | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543078 | PC Fix Thoracic Plate 70mm PEEK | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543108 | PC Fix Graphic Case | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543115 | PC Fix Clamp/Drill Guide Top | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543122 | PC Fix Clamp/Drill Guide Bottom | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543139 | PC Fix Compression Clamp | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543146 | PC Fix 3.2mm Drill Dental Latch | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543184 | PC Fix Implant Caddy | Chest Wall Innovations, Inc. | 2026-06-01 |
| 00850080543092 | PC Fix 3.2mm Drill Brad Point QC | Chest Wall Innovations, Inc. | 2026-06-01 |
| 07901125602533 | Expert Knotless | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2026-05-28 |
| 00888867251960 | Arthrex® | ARTHREX, INC. | 2017-11-28 |
| 00888867251939 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 07613153051794 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613153051787 | ASNIS | Stryker GmbH | 2015-09-24 |
| 20886982236965 | NA | Synthes GmbH | 2015-09-14 |
| 20886982236958 | NA | Synthes GmbH | 2015-09-14 |
| 20886982182545 | NA | Synthes GmbH | 2015-09-14 |
| 10886982120991 | NA | Synthes GmbH | 2015-09-14 |
| 10886982120977 | NA | Synthes GmbH | 2015-09-14 |
| 10886982120960 | NA | Synthes GmbH | 2015-09-14 |
| 10886982055583 | NA | Synthes GmbH | 2015-09-14 |
| 10886982055569 | NA | Synthes GmbH | 2015-09-14 |
| 10886982055552 | NA | Synthes GmbH | 2015-09-14 |