510(k) K181781
- Device
- DynaClipTM Bone Staple
- Applicant
- MedShape, Inc.
- 510(k) number
- K181781
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-05
- Date received
- 2018-07-03
- 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
- Jack Griffis
- Address
- 1575 Northside Dr. Suite 440 Atlanta GA US 30318 30318
FDA Registration Numbers#
- 3008812251
- 3026576110
- 3017980495
- 3015974593
- 3041276415
- 8030965
- 3010041511
- 3010622588
- 3004464325
- 3006272282
- 3010673850
- 1721676
- 1020279
- 1221934
- 1423662
- 3008034554
- 9610622
- 3003236702
- 3011683674
- 1043534
- 3014004349
- 2246552
- 3027848094
- 3007113169
- 3023852420
- 3030627814
- 1833920
- 1835831
- 1226183
- 3014302784
- 3002719998
- 2027754
- 3002807310
- 3015946784
- 1424263
- 1051526
- 9710629
- 3026586698
- 3009812190
- 2244478
- 3005180920
- 3010041693
- 3012478585
- 3012329552
- 3006017180
- 2320767
- 3031160399
- 1835296
- 3012818475
- 3032588003
- 3008559295
- 3002807314
- 3011623994
- 8010944
- 3030183061
- 3007993775
- 3016727307
- 2650143
- 3018094310
- 3009540749
- 3013700547
- 9614209
- 3010400367
- 3014314623
- 3014527966
- 1017294
- 1058584
- 2183967
- 2245304
- 1000461041
- 8044102
- 3008650117
- 3013176080
- 3015718210
- 3010123172
- 3008837339
- 3006498370
- 3015200653
- 3027071765
- 2936485
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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