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 |
|---|---|---|---|
| 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 |
| K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025-04-02 |
| K250304 | TITANEX Screw Systems | Vilex, LLC | 2025-03-05 |
| K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | 2025-02-05 |
| K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. | 2025-01-31 |
| K243195 | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2025-01-10 |
| K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024-12-04 |
| K233567 | OsteoCoil™ Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation Dba Conventus Flower Ortho | 2024-11-22 |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | Tigon Medical | 2024-10-29 |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024-10-09 |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2024-10-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850070500248 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500378 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500361 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500354 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500347 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500330 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500323 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500316 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500309 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500293 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500286 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500279 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500262 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500255 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500231 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500224 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500217 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500200 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500194 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500187 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500170 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500163 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500156 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500149 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500132 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10850070500125 | CurvaFix® Low Profile Implant | CURVAFIX, INC. | 2025-10-22 |
| 10855068008010 | CurvaFix® IM Implant | CURVAFIX, INC. | 2021-08-11 |
| 10855068008003 | CurvaFix® IM Implant | CURVAFIX, INC. | 2021-08-11 |
| 10886982033079 | VA-LCP | Synthes GmbH | 2015-09-14 |
| 10886982030054 | LCP | Synthes GmbH | 2015-09-14 |