510(k) K220906
- Device
- SECURE-LOCK
- Applicant
- Xiros Ltd
- 510(k) number
- K220906
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-22
- Date received
- 2022-03-29
- 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
- Steve Curran
- Address
- Springfield House Ln., Whitehouse Ln. Leeds GB LS17 7UE LS17 7UE
FDA Registration Numbers#
- 3010667733
- 3014314623
- 1720929
- 3034676720
- 2183946
- 1221934
- 3001592626
- 3006272282
- 3006524618
- 3025603301
- 3007993775
- 3008812251
- 9611274
- 3012103978
- 1043534
- 1220477
- 2245304
- 3014004349
- 3008114965
- 3009732568
- 3021226419
- 1220246
- 3021008900
- 3042903229
- 3011500362
- 3017191784
- 3015806723
- 3004983210
- 1833506
- 3009381600
- 2184171
- 3010673850
- 3010400367
- 3012329552
- 1048735
- 3002807295
- 9617297
- 3015440604
- 3012883081
- 3004993707
- 3006498370
- 3027553380
- 3004893332
- 2183967
- 2027487
- 3016851379
- 3011683674
- 3004961578
- 3005809810
- 9613910
- 3013700547
- 3013365802
- 3012966183
- 3022142628
- 3002579136
- 3008793310
- 9710629
- 3014315560
- 3014286836
- 3017196117
- 1834331
- 1020279
- 3011230048
- 3027339877
- 1835831
- 3014554088
- 3014252644
- 3006946279
- 3009746186
- 3016112537
- 3002949614
- 1320894
- 3011302058
- 3004638532
- 2244478
- 1032347
- 3011137372
- 3015231789
- 3015780293
- 3019269298
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 |
| 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 |
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