510(k) K203465
- Device
- OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
- Applicant
- OSSIO Ltd.
- 510(k) number
- K203465
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-06
- Date received
- 2020-11-24
- 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
- Taly Lindner
- Address
- 8 Hatochen St. Caesarea IL 3079861 3079861
FDA Registration Numbers#
- 1834331
- 3010329663
- 3013540005
- 3020745223
- 3010462278
- 3010863450
- 3009746186
- 8030965
- 3017980495
- 1221053
- 2431166
- 3006513362
- 1526534
- 3012329552
- 3012755988
- 3016438694
- 1720929
- 2245304
- 1043534
- 3002807315
- 3030655570
- 1828464
- 3012358417
- 3008951116
- 3006638824
- 2183967
- 3027242374
- 3006395932
- 3003477135
- 3042285592
- 3008650117
- 3011580264
- 3019455
- 3008749819
- 3004893332
- 3009732568
- 1124621
- 8031020
- 3009189869
- 8010177
- 3003236702
- 1822565
- 3008793310
- 3015806723
- 3015131017
- 3014833750
- 3010673777
- 3015895045
- 3008110533
- 3006801265
- 3010400367
- 1833920
- 2020601
- 3013176080
- 2530154
- 3011683674
- 3014129047
- 3009554293
- 3014315669
- 1054811
- 3005827567
- 1720747
- 3040335671
- 3007366790
- 9617297
- 3011500362
- 3011302058
- 3005641619
- 1017294
- 3012818475
- 2028632
- 3026032087
- 3009417901
- 1649518
- 3009141957
- 1424263
- 3013365802
- 9615765
- 1643264
- 3004635447
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