510(k) K131061
- Device
- RESTORE BUNION CORRECTION SYSTEM
- Applicant
- NEXTREMITY SOLUTIONS
- 510(k) number
- K131061
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-28
- Date received
- 2013-04-16
- 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
- JANET WEBB
- Address
- 54 Broad St., Suite 200 Red Bank NJ US 07701 07701
FDA Registration Numbers#
- 3021393544
- 3026576110
- 8030965
- 1017294
- 3012966183
- 3010041693
- 3024021261
- 3031160399
- 3027534459
- 3002579136
- 3007366790
- 3010041430
- 3017191784
- 3011580264
- 2936485
- 3017980495
- 8031020
- 3009971621
- 3015539532
- 3015542154
- 3017196117
- 3014262693
- 3013176080
- 1030489
- 3013820441
- 3010673777
- 3015440604
- 3036756245
- 1226544
- 2245304
- 1220246
- 3010622588
- 1834379
- 3004638532
- 1061927
- 3015946784
- 1043534
- 1220477
- 3005827567
- 1222928
- 3012275107
- 3008951116
- 2028632
- 3006498370
- 3012478585
- 3005941719
- 3004365956
- 1058584
- 9710629
- 3014273424
- 2648666
- 2183946
- 1319660
- 3020899789
- 3012818475
- 3020704423
- 1054811
- 1020279
- 3007125392
- 3009110133
- 3015231789
- 1051526
- 3032588003
- 2032098
- 3006017180
- 1000461041
- 8010257
- 3008650117
- 9610622
- 3007420745
- 3011683674
- 3025141
- 3009882462
- 2244478
- 3010273872
- 3019356409
- 3012470322
- 3004464325
- 3030627814
- 3002907620
Source Documents#
Other 510(k) Records For Product Code JDR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K231458 | Extremity Staple | Restor3D | 2023-08-03 |
Legacy Summary#
summary
FDA Review#
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