510(k) K180544
- Device
- DePuy Synthes Static Staples
- Applicant
- Synthes (USA) Products, LLC
- 510(k) number
- K180544
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-24
- Date received
- 2018-03-01
- 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
- Suchitra Basu
- Address
- 1301 Goshen Pkwy. West Chester PA US 19380 19380
FDA Registration Numbers#
- 3010667733
- 3010041693
- 3014314623
- 1720929
- 3008837339
- 2183946
- 1221934
- 3034676720
- 3012478585
- 3006272282
- 3005497913
- 3025603301
- 3007993775
- 3008812251
- 3015200653
- 3004915132
- 1043534
- 1220477
- 2245304
- 3014004349
- 3002719998
- 3008114965
- 1220246
- 1047843
- 3017191784
- 3014273424
- 3015806723
- 3017210488
- 3004983210
- 1833506
- 8044102
- 2030624
- 3007289093
- 1219930
- 3026576110
- 1835296
- 3012329552
- 3009812190
- 3010673850
- 3010123256
- 1038671
- 3002807295
- 1051526
- 3010400367
- 3027848094
- 1048735
- 3009116370
- 3015440604
- 3012883081
- 3014967969
- 3030627814
- 3006498370
- 3011683674
- 2320767
- 2183967
- 2246552
- 3016851379
- 3010273872
- 3008236846
- 3016084569
- 1222928
- 2650143
- 3013700547
- 3013365802
- 3020703621
- 3012966183
- 3002579136
- 9710629
- 3018094310
- 3017196117
- 1020279
- 3011230048
- 3027339877
- 1835831
- 3016248538
- 1647149
- 3009746186
- 3002949614
- 3011302058
- 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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