510(k) K221283
- Device
- Hammertoe Truss System (HTS)
- Applicant
- 4Web Medical, Inc.
- 510(k) number
- K221283
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-06
- Date received
- 2022-05-03
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lewis Harrison
- Address
- 2801 Network Blvd. Suite 620 Frisco TX US 75034 75034
FDA Registration Numbers#
- 3008812251
- 3014129047
- 3017980495
- 3015974593
- 3007109793
- 3012755988
- 8030965
- 3007923096
- 3010041511
- 3004464325
- 3012103978
- 3010673850
- 3004748528
- 3006272282
- 3025266
- 3015399803
- 1020279
- 3005061536
- 1221934
- 3004993707
- 2025102
- 1423662
- 1835572
- 3011302692
- 1720747
- 9610622
- 3003236702
- 3011683674
- 3009141957
- 1043534
- 3014527928
- 1032347
- 3014004349
- 3042285592
- 3006946279
- 3015967359
- 3023852420
- 1833920
- 1835831
- 1226183
- 3014302784
- 8010468
- 3002807310
- 3015946784
- 1424263
- 3027553380
- 8043862
- 9710629
- 3006513362
- 3009812190
- 2244478
- 3012770122
- 3005180920
- 3012329552
- 3042903229
- 3011127597
- 3006017180
- 3008102042
- 3022472578
- 9680825
- 3012818475
- 3008559295
- 3014315669
- 3030183061
- 3000270450
- 3003418325
- 3007993775
- 3016727307
- 3010383847
- 3015895045
- 3013700547
- 3009540749
- 3010400367
- 3014286836
- 3014314623
- 3030655570
- 3001592626
- 3011500362
- 1017294
- 1058584
Source Documents#
Other 510(k) Records For Product Code HTY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026-08-28 |
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | 2025-08-01 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | 2023-12-01 |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023-09-14 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022-02-17 |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 |