510(k) K230724
- Device
- arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
- Applicant
- Novastep
- 510(k) number
- K230724
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-04
- Date received
- 2023-03-16
- 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
- No
Applicant Contact#
- Contact
- Gilles Audic
- Address
- 2, Allée Jacques Frimot Rennes FR 35000 35000
FDA Registration Numbers#
- 3002949614
- 3020584246
- 2245304
- 3011623994
- 8044102
- 1526711
- 3014004349
- 1222928
- 3019356409
- 3025141
- 1219602
- 1834379
- 3020899789
- 2031009
- 3011230048
- 3010041420
- 3010041511
- 2320767
- 3003477135
- 1020279
- 3009973699
- 3010041430
- 3008868758
- 3010162973
- 3008236846
- 1225838
- 3007420745
- 3015780293
- 3031160399
- 3015173212
- 2183967
- 3010060157
- 3009110133
- 1226544
- 1054811
- 2030624
- 3013011598
- 3014967969
- 2027754
- 3041276415
- 3027339877
- 3009971621
- 3010123256
- 1221934
- 2648666
- 3006783837
- 3007993775
- 3007289093
- 3014302784
- 3014207283
- 3008749819
- 1030489
- 8031020
- 3006638824
- 8043792
- 3032588003
- 3016851379
- 9614209
- 3009812190
- 3030183061
- 3015200653
- 3003604053
- 3030627814
- 3039081660
- 3009631939
- 1450662
- 3004579081
- 3016248538
- 1833986
- 3010667733
- 3013365802
- 3002807315
- 3002807310
- 3013176080
- 3002907620
- 3002807295
- 3027242374
- 3007663067
- 3027534459
Source Documents#
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 |
| K232990 | A’TOMIC™ Nitinol Fixation System | Rmr Ortho, LLC | 2024-01-12 |
| 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 |