510(k) K902567
- Device
- STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES
- Applicant
- A. HENNISS
- 510(k) number
- K902567
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-10
- Date received
- 1990-06-11
- 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
- GEORGE O SHECTER
- Address
- 18321 Ventura Blvd., Suite 1010 Tarzana CA US 91356 91356
FDA Registration Numbers#
- 3011301313
- 1221934
- 3013176080
- 1417592
- 3008951116
- 3015718210
- 3017210488
- 1526711
- 3006460162
- 3026586698
- 2029275
- 3010041511
- 3010462278
- 3019269298
- 3011874600
- 1835831
- 1647149
- 3010123256
- 1030489
- 1226183
- 3016851379
- 3004365956
- 1833920
- 3008110533
- 1038671
- 3032588003
- 1048735
- 3026576110
- 3003604053
- 1319660
- 1450662
- 2936485
- 3023808054
- 3012470322
- 3034676720
- 3017980495
- 3015183635
- 3010470577
- 1833986
- 2032098
- 3009110133
- 3005827567
- 3007125392
- 3027848094
- 3020584246
- 3025141
- 3021393544
- 3010052483
- 3015539532
- 1825034
- 3003387384
- 9614209
- 3015974593
- 3007583504
- 3006783837
- 9681465
- 3027534459
- 3008749819
- 3007113169
- 3009631939
- 3015207155
- 2027754
- 3008812251
- 3004638532
- 1424263
- 3005941719
- 2183946
- 1219602
- 3010047402
- 3012478585
- 3035366890
- 3010273872
- 3014302784
- 3010673850
- 1043534
- 2530154
- 3006638824
- 3009540749
- 3012818475
- 9710629
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases