510(k) K853267
- Device
- DAY STAPLE
- Applicant
- PROTEK, INC.
- 510(k) number
- K853267
- Product code
- JDR
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1985-09-06
- Date received
- 1985-08-05
- 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#
- Contact
- KENNETH EPLING
- Address
- 2601 Fortune Cir. E. Suite 105b 2601 Fortune Cir. E. Suite 105b Indianapolis IN US 46241 46241
FDA Registration Numbers#
- 3007593722
- 2183946
- 3010123172
- 3014967969
- 3013176080
- 3009973699
- 3010673850
- 1423662
- 3012275107
- 3027071765
- 3006460162
- 3008951116
- 1221934
- 3012470322
- 1834379
- 8044102
- 3002807315
- 1833506
- 3015974593
- 3014262693
- 3012818475
- 3014302784
- 1526534
- 3009971621
- 3010400367
- 3011302058
- 3004464325
- 1030489
- 3009110133
- 3007420745
- 3002579136
- 2031009
- 3008868758
- 1835296
- 3017196117
- 1226544
- 2650143
- 3007113169
- 3030627814
- 3016727307
- 3012478585
- 1226183
- 3010041693
- 2245304
- 3019807891
- 3003477135
- 3012883081
- 3010047402
- 1051526
- 3020703621
- 1721676
- 1220477
- 3015542154
- 3027848094
- 8010944
- 3019356409
- 1058584
- 2183967
- 3041276415
- 3015806723
- 3008812251
- 3009513193
- 3031240334
- 8043792
- 3002807310
- 3007503337
- 1038671
- 1020279
- 3015200653
- 3002949614
- 1828288
- 3010178296
- 3008034554
- 3014273424
- 2648666
- 3009540749
- 3009423112
- 3008110533
- 3035366890
- 3004638532
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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