Product code HWC
- Device name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- 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 |
|---|---|---|---|
| K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | OsteoCentric Technologies | 2026-10-02 |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | 2026-09-25 |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026-09-23 |
| K254280 | F.A.S.T Screw | Steps Ortho | 2026-09-21 |
| K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | 2026-09-04 |
| K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026-08-24 |
| K262344 | Large Compression Screws | TriMed, Inc. | 2026-08-12 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026-06-25 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | 2026-03-18 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 |
| K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025-11-06 |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025-10-10 |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025-10-08 |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025-08-29 |
| K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | 2025-08-27 |
| K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025-08-15 |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | 2025-06-13 |
| K243943 | TriMed® Compression Screws | TriMed, Inc. | 2025-04-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08057717550597 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2026-09-30 |
| 08057717550580 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2026-09-30 |
| 08057717550566 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2026-09-30 |
| 08057717550542 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2026-09-30 |
| 08057717550535 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2026-09-30 |
| 08057717550382 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550573 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550559 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550528 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550504 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550481 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550467 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550443 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550429 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550405 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550368 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550313 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550290 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550061 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550047 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550030 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550023 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550016 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550009 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-09 |
| 08057717550276 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-08 |
| 08057717550252 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2025-07-08 |
| 08057717550054 | BRM TOOL Titanium Screw | BRM EXTREMITIES SRL | 2023-04-19 |
| 00888867354067 | Arthrex® | ARTHREX, INC. | 2020-12-15 |
| 00888867096066 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 07613327036176 | Washer | Howmedica Osteonics Corp. | 2015-09-24 |