510(k) K232387
- Device
- Treace Medical Concepts (TMC) Compression Implant System
- Applicant
- Treace Medical Concepts
- 510(k) number
- K232387
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-28
- Date received
- 2023-08-09
- 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
- Brittany Grochala
- Address
- 100 Palmetto Park Pl. Ponte Vedra FL US 32081 32081
FDA Registration Numbers#
- 3002949614
- 2031009
- 1221934
- 3013700547
- 3017980495
- 3015718210
- 3004915132
- 3015200759
- 1835831
- 3010331645
- 3015806723
- 8010944
- 3006783837
- 1526534
- 3002807314
- 3014314623
- 3027242374
- 3010622588
- 2320767
- 3031160399
- 1721676
- 1720929
- 1424263
- 3015974593
- 8010257
- 9681465
- 9614209
- 3003477135
- 3007583504
- 2936485
- 3002719998
- 1833986
- 3015440604
- 1647149
- 3012358417
- 1220246
- 3033509898
- 3039081660
- 3021336182
- 3013365802
- 3020899789
- 3026576110
- 3006272282
- 3009812190
- 1222928
- 1825034
- 3008114965
- 3010178296
- 1834379
- 3015200653
- 3030183061
- 3014262693
- 3007420745
- 2027754
- 3016851379
- 8030965
- 1833920
- 3005827567
- 1038671
- 3009513193
- 1054811
- 3035366890
- 2028632
- 1220477
- 1417592
- 3017210488
- 2245304
- 3007113169
- 3017196117
- 3011230048
- 3010389204
- 3012818475
- 3015231789
- 1051526
- 3032588003
- 1649518
- 3025141
- 3015542154
- 9610622
- 3004638532
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 |
| 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 |
| 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 |