510(k) K251362
- Device
- PediFlex? Flexible Nail System
- Applicant
- OrthoPediatrics Corp.
- 510(k) number
- K251362
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-24
- Date received
- 2025-05-01
- 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
- Jessica Powers
- Address
- 2850 Frontier Dr. Warsaw IN US 46582 46582
FDA Registration Numbers#
- 1226191
- 3002949614
- 2031009
- 3022518322
- 1221934
- 3013700547
- 3017980495
- 3007539489
- 1835831
- 9680619
- 3010331645
- 1032347
- 3015806723
- 2031093
- 1836357
- 3006783837
- 1828464
- 1526534
- 1818910
- 1000517406
- 3014314623
- 3027242374
- 3015399803
- 3007109793
- 3005809810
- 1424263
- 3013540005
- 1720929
- 3015974593
- 3004748528
- 9681465
- 3005641619
- 3003477135
- 2183449
- 3009973336
- 3011137372
- 2936485
- 1833986
- 3015440604
- 3002806470
- 2249615
- 3012358417
- 3014833750
- 3004635447
- 3016112537
- 1220246
- 3033509898
- 1822565
- 3006524618
- 3013365802
- 3020899789
- 3021336182
- 3025266
- 2183785
- 3012770122
- 3040335671
- 3006272282
- 3006694268
- 1825034
- 3008114965
- 3010155648
- 3010178296
- 3010370500
- 3004893332
- 3030183061
- 3014262693
- 3007420745
- 3015895045
- 8030965
- 1833920
- 3016851379
- 3010863450
- 3009732568
- 3005827567
- 3007923096
- 1054811
- 3009513193
- 3009141957
- 3035366890
- 2028632
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 |
| 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 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 |