510(k) K832884
- Device
- FIXATION STAPLE DRIVER/EXTRACTOR
- Applicant
- WARSAW ORTHOPEDIC, INC.
- 510(k) number
- K832884
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-20
- Date received
- 1983-08-26
- Regulation
- 888.3030
- Classification name
- Staple, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009746186
- 3012818475
- 3018094310
- 3008868758
- 3030627814
- 3011580264
- 3002579136
- 8043792
- 3013011598
- 3014302784
- 1226544
- 3010123172
- 3008837339
- 3007366790
- 3008749819
- 3019807891
- 3010047402
- 3025141
- 3005180920
- 3007125392
- 2244478
- 3007993775
- 1225838
- 3010060157
- 3007289093
- 3016727307
- 2530154
- 3004638532
- 3003139373
- 3008114965
- 3003477135
- 3026593233
- 3015806723
- 3004976965
- 3004915132
- 3011874600
- 3033509898
- 3008812560
- 3006017180
- 3012329552
- 2936485
- 3002807310
- 3015718210
- 2246552
- 3015200759
- 3010400367
- 3010470577
- 3010667733
- 3021336182
- 3000203391
- 2031009
- 3011230048
- 3005827567
- 1833986
- 3010462278
- 3015183635
- 3024021261
- 3026576110
- 1835831
- 2648666
- 3008236846
- 3013820441
- 1417592
- 3036756245
- 3009540749
- 3013700547
- 3034676720
- 3031160399
- 1017294
- 3011302058
- 3013365802
- 1018470
- 9615765
- 3007663067
- 3010041499
- 3012478585
- 3017980495
- 3020899789
- 3010162973
- 3014273424
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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