510(k) K232990
- Device
- ATOMIC Nitinol Fixation System
- Applicant
- Rmr Ortho, LLC
- 510(k) number
- K232990
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-12
- Date received
- 2023-09-22
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Joe Ritz
- Address
- 461 Pr 4749 Castroville TX US 78009 78009
FDA Registration Numbers
- 1423662
- 1450662
- 1833506
- 3026586698
- 3014967969
- 3005180920
- 3006498370
- 3013820441
- 3009540749
- 3023808054
- 1649390
- 2650143
- 3013176080
- 3002807315
- 3009973699
- 3014527966
- 1043534
- 1000461041
- 3016727307
- 3010060157
- 3004464325
- 9617083
- 1835831
- 3010041430
- 3010389204
- 3012275107
- 3004579081
- 8044102
- 2183946
- 2320767
- 2031009
- 3023852420
- 2032098
- 3000203391
- 1018470
- 3020703621
- 3009513193
- 1824199
- 3007420745
- 1833920
- 3002579136
- 3007503337
- 3015806723
- 3025603301
- 3011301313
- 3012818475
- 3034676720
- 2028632
- 1043653
- 2246552
- 1319660
- 2027754
- 3006460162
- 3007289093
- 1721676
- 3015718210
- 3009746186
- 3007593722
- 3010041693
- 3010162973
- 1226183
- 3009116370
- 3004976965
- 3027339877
- 3002949614
- 3017210488
- 3002807314
- 3010123172
- 3011580264
- 3017196117
- 3010673777
- 3009423112
- 3003139373
- 3014262693
- 3012966183
- 3010331645
- 3008110533
- 3015539532
- 3020704423
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code JDR
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-05-11 |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-02-16 |