510(k) K911505
- Device
- FIXATION WIRE
- Applicant
- SIMPEX, INC.
- 510(k) number
- K911505
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-12
- Date received
- 1991-04-04
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD GORSKI
- Address
- 13775 SW Larch Pl., Suite 26 Beaverton OR US 97005 97005
FDA Registration Numbers#
- 3003236702
- 3031240334
- 3010462278
- 3010389204
- 3011127597
- 3013011598
- 1649518
- 9611274
- 3010470577
- 3020899789
- 3022472578
- 2249615
- 3009540749
- 3002579136
- 9680619
- 1320894
- 3011500362
- 3030655570
- 3007109793
- 3021336182
- 3009110133
- 3014302784
- 3011137372
- 3015967359
- 3022518322
- 3015440604
- 3027339877
- 1226544
- 2245304
- 1043534
- 3042285592
- 3004635447
- 3002806470
- 3025603301
- 3033509898
- 8010468
- 3004748528
- 3011874600
- 3010400367
- 3011580264
- 3013700547
- 1828288
- 3016496998
- 3014833750
- 3034676720
- 3004215117
- 3010331645
- 3005809810
- 2184171
- 1836357
- 3005061536
- 1526534
- 1833920
- 3012755988
- 3002949614
- 2028632
- 1222773
- 2530154
- 3042903229
- 3027242374
- 3010383847
- 1226183
- 2249529
- 3006694268
- 2031093
- 3030183061
- 3004638532
- 8010177
- 3015151147
- 2031009
- 3006017180
- 1833986
- 3005536892
- 3019269298
- 3006638824
- 3006513362
- 3009973505
- 3004893332
- 3025266
- 2437731
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262126 | Cerclage Wires;K-wires;Steinmann Pins | MK Medical GmbH | 2026-10-22 |
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026-08-28 |
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | 2025-08-01 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | 2023-12-01 |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023-09-14 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 |
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