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#
- 3002949614
- 9617297
- 3011302692
- 2245304
- 3004748528
- 3030655570
- 3007304202
- 3004215117
- 2249529
- 2431166
- 3015967359
- 3014004349
- 3019356409
- 3025141
- 3016438694
- 3011127597
- 3020899789
- 2031009
- 3011230048
- 3005562917
- 3009141957
- 3010041511
- 3009381600
- 3026032087
- 1226191
- 3003477135
- 1020279
- 3009973699
- 2183449
- 3008729892
- 3015212339
- 9616696
- 3008868758
- 3010162973
- 3001592626
- 3005536892
- 3007420745
- 3015780293
- 8010468
- 3022518322
- 2183967
- 3015453963
- 3009110133
- 3010155648
- 1054811
- 3014315669
- 3013011598
- 3014315560
- 1226544
- 3006524618
- 3027339877
- 3009971621
- 1221934
- 3005641619
- 2648666
- 1000517406
- 3006783837
- 3009973336
- 3007993775
- 1822565
- 3014302784
- 3014833750
- 3008749819
- 3015895045
- 8031020
- 3004993707
- 3040335671
- 2249615
- 9613910
- 3004893332
- 3006638824
- 8043792
- 3013680140
- 1032347
- 2184171
- 3016851379
- 2437731
- 3014680795
- 3030183061
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