510(k) K153638
- Device
- Bicortical Fixation Screw & Washer Nut System
- Applicant
- FIRST RAY LLC
- 510(k) number
- K153638
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-04-19
- Date received
- 2015-12-18
- 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
- No
Related Records
Applicant Contact
- Contact
- ROBERT HOY
- Address
- 124 S. 600 W. Suite 100 Logan UT US 84321 84321
FDA Registration Numbers
- 3014273424
- 3010673777
- 3005064037
- 3006563559
- 3014763043
- 3013756169
- 3010622588
- 3013194153
- 3011354099
- 9610622
- 3013700547
- 3010287737
- 2320767
- 3010400367
- 3008110533
- 3010041993
- 3010047454
- 3025318945
- 3032588003
- 2020601
- 9613910
- 1047843
- 2936485
- 2032521
- 1421101
- 3015895045
- 3038503572
- 1043653
- 3009540749
- 3008868758
- 1644408
- 2028632
- 2245304
- 2183967
- 3016669046
- 3010097171
- 3011301313
- 3022295665
- 3017980266
- 1032347
- 3010560653
- 9617083
- 1219930
- 3008729892
- 3010120148
- 3000170817
- 1220477
- 3011530718
- 3009888740
- 3003761012
- 3008583793
- 1287329
- 3010047402
- 9611274
- 3007766601
- 3015410662
- 3010273872
- 8031010
- 3017528621
- 3016261131
- 3006272282
- 3009417901
- 3021010222
- 3011580264
- 3017191784
- 3027553380
- 3015831087
- 3002806470
- 1064129
- 1036836
- 3022928161
- 3009337401
- 3011230048
- 3010887276
- 1822565
- 3004961578
- 3014644608
- 8043971
- 3007700286
Source Documents
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 |
Legacy Summary
summary
FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases