510(k) K230750
- Device
- OSSIOfiber® Cannulated Trimmable Fixation Nail
- Applicant
- OSSIO , Ltd.
- 510(k) number
- K230750
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-13
- Date received
- 2023-03-17
- 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#
- 3012770122
- 3012103978
- 3008812560
- 3013680140
- 3004983210
- 3011127597
- 3006395932
- 3007366790
- 3030183061
- 3015895045
- 3010178296
- 3010041499
- 3008868758
- 1828464
- 3010863450
- 2183785
- 1649390
- 3019356409
- 2936485
- 1124621
- 1825034
- 1833506
- 1833986
- 1423662
- 3009189869
- 3004893332
- 1450662
- 3019455
- 1221934
- 3014252644
- 3026032087
- 3004638532
- 3008749819
- 3005562917
- 3015946784
- 8043862
- 3006801265
- 3009971621
- 3012966183
- 3009381600
- 3008559295
- 1643264
- 3036756245
- 1017294
- 1226183
- 3006272282
- 2244478
- 9680825
- 1822565
- 3011580264
- 3012329552
- 3015806723
- 3030655570
- 3014527928
- 3042285592
- 1000517406
- 3009631939
- 3013055499
- 1720929
- 3014315669
- 3002579136
- 3009540749
- 3025603301
- 3013700547
- 3017406274
- 3025141
- 3004993707
- 1048735
- 3007420745
- 3004215117
- 3012358417
- 3006498370
- 3010383847
- 3011500362
- 3035366890
- 3008729892
- 2032098
- 3006513362
- 3012818475
- 1649518
Source Documents#
Other 510(k) Records For Product Code HTY#
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|---|---|---|---|
| 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 |
| 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 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 |