510(k) K250251
- Device
- Eleganz Fusion Screw System (Fusion Screw System)
- Applicant
- Dev4
- 510(k) number
- K250251
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-13
- Date received
- 2025-01-28
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jeff Seavey
- Address
- 1002 Gemini St., Suite 129 Houston TX US 77058 77058
FDA Registration Numbers
- 1450662
- 3026586698
- 3016778139
- 9680619
- 3030926959
- 3023808054
- 1649390
- 3015131017
- 3009394448
- 1043534
- 3004464325
- 2031917
- 3001239363
- 1421101
- 3015453963
- 2183744
- 8044172
- 3012086398
- 3023852420
- 1834331
- 3003541440
- 3013756169
- 3015075784
- 3005290844
- 3014522470
- 3013194153
- 1833824
- 2032521
- 2649614
- 2031093
- 3015410662
- 1643264
- 3004358587
- 1219655
- 3000170817
- 1319660
- 9611579
- 3017521423
- 3025114181
- 3003678543
- 1226183
- 3027339877
- 3002949614
- 1064858
- 3017210488
- 3007700286
- 3012429289
- 9612277
- 8010177
- 3010846112
- 2249697
- 3010863450
- 3019767615
- 3010331645
- 1531050
- 3008696586
- 3005029036
- 3006128100
- 2530154
- 1225838
- 3014279513
- 3027827832
- 3002962587
- 3010118938
- 3015173212
- 3012478585
- 3029933740
- 3006638824
- 3017191784
- 2183449
- 2183967
- 1060840
- 3008870565
- 3006001176
- 3002807295
- 3030514683
- 1061927
- 3009189869
- 3022518322
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810190980705 | Eleganz Fusion Screw System | Dev4 | 2025-10-01 |
| 00810190980682 | Eleganz Fusion Screw System | Dev4 | 2025-10-01 |
Other 510(k) Records For Product Code HWC
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |