510(k) K193533
- Device
- WIN Flexible Nail System
- Applicant
- Biomet Inc.
- 510(k) number
- K193533
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-02-20
- Date received
- 2019-12-20
- 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
- Dominique Dompor
- Address
- 56 E. Bell Dr., P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3015869493
- 1833920
- 3016759112
- 3002808145
- 3004358587
- 3015882686
- 3014527928
- 3035366890
- 3006694268
- 3013302242
- 3009417901
- 3003541440
- 3008868758
- 1064129
- 3009217531
- 3005874553
- 3007923096
- 1643264
- 3003525643
- 3000270450
- 3038503932
- 3010041499
- 3007366790
- 3019767615
- 3017528621
- 1828288
- 3016237080
- 3009116370
- 9680825
- 3006513362
- 1835251
- 3010303097
- 3017521423
- 1043653
- 3043543260
- 3014976005
- 3015877656
- 3004369035
- 2249615
- 3008791302
- 9615021
- 3015876273
- 3021008900
- 1643817
- 3009882675
- 3010120326
- 3010057495
- 3029933740
- 3009973505
- 8043792
- 3030714745
- 3015399803
- 3015212339
- 1058584
- 3025603301
- 3015440604
- 3009959868
- 9611390
- 1834331
- 9611813
- 3004638532
- 3003761012
- 9613910
- 3005497913
- 3014170143
- 3010120104
- 3011500362
- 3006017180
- 3008812560
- 3010220595
- 3014279513
- 3004142400
- 1720929
- 3009381600
- 3005076207
- 3010041430
- 3010863450
- 1722511
- 1822565
- 3015183635
Source Documents#
Other 510(k) Records For Product Code HTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 |
| 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 |
Legacy Summary#
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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