510(k) K991482
- Device
- UNI-CLIP STAPLE
- Applicant
- NEWDEAL S.A.
- 510(k) number
- K991482
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-06-03
- Date received
- 1999-04-28
- 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
- NORMAN F ESTRIN
- Address
- 9109 Copenhaver Dr. Potomac MD US 20854 20854
FDA Registration Numbers#
- 3027848094
- 3008812560
- 3004983210
- 3007366790
- 3030183061
- 3014527966
- 3005497913
- 3010178296
- 3010041499
- 3008868758
- 3016084569
- 1649390
- 3019356409
- 2936485
- 1825034
- 1833506
- 1833986
- 1423662
- 3012275107
- 3007113169
- 3008034554
- 1450662
- 3010060157
- 1221934
- 3004976965
- 3026586698
- 3004638532
- 3008749819
- 3015946784
- 3009971621
- 3012966183
- 3036756245
- 3008559295
- 8010257
- 8044102
- 1017294
- 3004365956
- 1226183
- 3006272282
- 2244478
- 3015200759
- 3011580264
- 3015718210
- 3012329552
- 3015806723
- 1824199
- 3010041430
- 3009631939
- 3013055499
- 1720929
- 3009540749
- 3002579136
- 3025603301
- 3025141
- 3013700547
- 1048735
- 3007420745
- 1721676
- 8010944
- 3012358417
- 3010123172
- 3006498370
- 3000203391
- 3002807314
- 3035366890
- 2032098
- 3014273424
- 3018094310
- 1647149
- 1834379
- 1222928
- 3012818475
- 1649518
- 1226544
- 3010622588
- 3019269298
- 3026576110
- 3003236702
- 1047843
- 3014302784
Source Documents#
Other 510(k) Records For Product Code JDR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-05-11 |
Legacy Summary#
summary
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