510(k) K232905
- Device
- Medline UNITE® REFLEX® Nitinol Staple Kit
- Applicant
- Medline Industries, LP
- 510(k) number
- K232905
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-19
- Date received
- 2023-09-19
- Regulation
- 888.3030
- Classification name
- Staple, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Mason
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers#
- 3011874600
- 3005497913
- 1721676
- 3027339877
- 3009631939
- 1824199
- 1226544
- 9681465
- 1833986
- 1220246
- 3010041693
- 3009116370
- 3034676720
- 3020703621
- 3007113169
- 3010673850
- 3010667733
- 3006498370
- 3010178296
- 3011230048
- 3006783837
- 3007583504
- 1000461041
- 3010462278
- 2936485
- 3012478585
- 3020704423
- 3015173212
- 1221934
- 3003236702
- 3008559295
- 1647149
- 3012329552
- 3003477135
- 3014302784
- 3025603301
- 3005941719
- 3012883081
- 3027242374
- 3016084569
- 3009423112
- 1526534
- 3010400367
- 1043534
- 3020899789
- 1649518
- 3015200653
- 8030965
- 3015946784
- 3009971621
- 3023808054
- 3021393544
- 1225838
- 3013055499
- 3013820441
- 3015200759
- 3016248538
- 3010041420
- 3002807314
- 9615765
- 3027848094
- 3027534459
- 1047843
- 3004464325
- 3038503932
- 2530154
- 3011301313
- 3017191784
- 3018094310
- 3009110133
- 2320767
- 8031020
- 3009417901
- 3007593722
- 1051526
- 2028632
- 1018470
- 2246552
- 1061927
- 3008812251
Source Documents#
Other 510(k) Records For Product Code JDR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262451 | Arthrex DynaNite Staples | Arthrex, Inc. | 2026-09-01 |
| 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 |
| 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 |