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
Related Records
Applicant Contact
- Contact
- Sanghyun Joung
- Address
- Robot Innovation Center Kiria 75, Nowon-Ru, Buk-Gu Rm. 202 Daegu KR 41496 41496
FDA Registration Numbers
- 3014262693
- 3022472578
- 2029275
- 3014129047
- 3010673777
- 2183785
- 3019455
- 3014315669
- 2183449
- 3022142628
- 3010041499
- 2437731
- 3008650117
- 2244478
- 3009826895
- 3014527928
- 1423662
- 3021008900
- 3010329663
- 1043653
- 3015974593
- 3006513362
- 9610622
- 2431166
- 3013700547
- 3005809810
- 3019356409
- 3016851379
- 8010177
- 3019269298
- 3033509898
- 3010400367
- 3008110533
- 3007304202
- 2020601
- 3009110133
- 3005562917
- 3014004349
- 9613910
- 3007993775
- 2936485
- 3002907620
- 3009971621
- 1421101
- 3009973505
- 3010331645
- 3010863450
- 3015895045
- 3008749819
- 3012755988
- 3012883081
- 3009540749
- 1221053
- 3017406274
- 2530154
- 1048735
- 3008868758
- 3014315560
- 2028632
- 2245304
- 3006395932
- 2183967
- 3011656326
- 3001592626
- 3040335671
- 3011301313
- 1018470
- 3010470577
- 3012103978
- 3008951116
- 1226191
- 1032347
- 3009189869
- 3022518322
- 9710629
- 3008729892
- 8043792
- 3014680795
- 1818910
Source Documents
Other 510(k) Records For Product Code HTY
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|---|---|---|---|
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| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 |