510(k) K262075
- Device
- Lapidus Screw Kit
- Applicant
- Relja Innovations, LLC
- 510(k) number
- K262075
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-22
- Date received
- 2026-06-22
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Robby Amiot
- Address
- 11220 W. Burleigh St. Wauwatosa WI US 53222 53222
FDA Registration Numbers#
- 3015869493
- 1833920
- 1222773
- 3002808145
- 3015231789
- 1000517406
- 3010047402
- 3004513872
- 3008132398
- 1048735
- 2648666
- 3015882686
- 1047843
- 9610726
- 3017191784
- 3010846112
- 1226544
- 3009417901
- 3017209758
- 3009656988
- 3009217531
- 3005983700
- 3005874553
- 3011388423
- 3017435639
- 3014342096
- 3016084569
- 1319639
- 3002719998
- 1221053
- 9681465
- 3038503932
- 3015167917
- 3010060157
- 3014262693
- 1064017
- 3016660811
- 3006498370
- 9710312
- 3016237080
- 3012724179
- 2531195
- 3010162973
- 3011127597
- 3006513362
- 3009189869
- 1835251
- 9617083
- 3010531069
- 3002949614
- 3010123172
- 3013014058
- 3027553380
- 3032314868
- 3010560653
- 1060840
- 3005004799
- 3012478585
- 3035785605
- 3015718210
- 9610921
- 3006791286
- 3020704423
- 2249615
- 3023272531
- 1287329
- 3023808054
- 3024813436
- 3015075784
- 3009882675
- 3010120326
- 3012711663
- 3015398319
- 3011623994
- 3008337808
- 9611579
- 3025318945
- 3007334927
- 3004499989
Source Documents#
Other 510(k) Records For Product Code HWC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |