510(k) K250315
- Device
- RONAVIS – FX (FX-001)
- Applicant
- AIRS, Inc.
- 510(k) number
- K250315
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-01
- Date received
- 2025-02-04
- 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
- N
Applicant Contact#
- Contact
- Sanghyun Joung
- Address
- Robot Innovation Center Kiria 75, Nowon-Ru, Buk-Gu Rm. 202 Daegu KR 41496 41496
FDA Registration Numbers#
- 3011874600
- 9680619
- 3014315560
- 3010155648
- 2184171
- 3011500362
- 3027339877
- 3009631939
- 3004635447
- 3013302242
- 1226191
- 1222773
- 3022518322
- 1226544
- 9681465
- 1833986
- 1220246
- 3005562917
- 3030655570
- 1320894
- 3034676720
- 3010673850
- 3014554088
- 3010667733
- 3006498370
- 1834331
- 3010178296
- 3011230048
- 3006783837
- 3008021110
- 3004215117
- 2183785
- 1000461041
- 3010462278
- 2936485
- 3008729892
- 3020704423
- 2431166
- 1221934
- 3003236702
- 3022142628
- 3008559295
- 3021226419
- 3009973336
- 3012329552
- 3003477135
- 3014302784
- 3025603301
- 3004893332
- 3012883081
- 3027242374
- 3006395932
- 9613369
- 3009423112
- 1526534
- 3010400367
- 1043534
- 3020899789
- 1649518
- 3003418325
- 1032347
- 8030965
- 3014315669
- 3015946784
- 3014680795
- 3006694268
- 3009971621
- 3015895045
- 3021393544
- 3013055499
- 3019455
- 9615765
- 1835572
- 3004464325
- 3038503932
- 2530154
- 3011301313
- 3006524618
- 3017191784
- 3009110133
Source Documents#
Other 510(k) Records For Product Code HTY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026-08-28 |
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| 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 |