510(k) K262451
- Device
- Arthrex DynaNite Staples
- Applicant
- Arthrex, Inc.
- 510(k) number
- K262451
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-01
- Date received
- 2026-07-17
- Regulation
- 888.3030
- Classification name
- Staple, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Konrad Wolfmeyer
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3021393544
- 3016248538
- 3004464325
- 1833506
- 3012883081
- 1226544
- 3003236702
- 1038671
- 3010047402
- 3008812560
- 1220477
- 3032588003
- 1221934
- 3010123172
- 3014314623
- 1043534
- 3006638824
- 3017191784
- 3026576110
- 3010331645
- 3039081660
- 3009116370
- 1030489
- 3007993775
- 3000203391
- 3027339877
- 3026586698
- 9617083
- 3012358417
- 3009882462
- 3005497913
- 3008749819
- 3010622588
- 3019269298
- 3007503337
- 2320767
- 3010673777
- 3015200759
- 3014262693
- 3003604053
- 3002807314
- 3013700547
- 3024021261
- 3004579081
- 3005180920
- 2183946
- 3027242374
- 3002949614
- 3015440604
- 3014527966
- 3013055499
- 1417592
- 2246552
- 3011683674
- 1051526
- 3010041430
- 3007420745
- 3010123256
- 1018470
- 3008034554
- 1647149
- 3010470577
- 8030965
- 2245304
- 3011296511
- 3015542154
- 3012275107
- 2650143
- 3008110533
- 1833986
- 3002579136
- 3008650117
- 3009423112
- 1825034
- 3007663067
- 3008868758
- 8031020
- 3013176080
- 3010178296
- 1828288
Source Documents#
Other 510(k) Records For Product Code JDR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026-08-06 |
| K250712 | Linkt Compression Staple System | Trax Surgical | 2025-05-14 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025-04-11 |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025-01-31 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024-09-06 |
| K240212 | COGNiTiON™ Staple System | Ortho Solutions UK , Ltd. | 2024-02-23 |
| K232990 | A’TOMIC™ Nitinol Fixation System | Rmr Ortho, LLC | 2024-01-12 |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | 2023-12-04 |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023-10-19 |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023-08-30 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023-08-28 |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | 2023-08-11 |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023-08-09 |
| K231458 | Extremity Staple | Restor3D | 2023-08-03 |