510(k) K213982
- Device
- Pacific Instruments Orthopedic Fixation Pins And Wires / Kirschner / Guide Wires
- Applicant
- Pacific Instruments
- 510(k) number
- K213982
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-17
- Date received
- 2021-12-20
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tracy Sullivan
- Address
- 438 Hobron Ln., Suite 204 Honolulu HI US 96815 96815
FDA Registration Numbers#
- 3003755939
- 1833920
- 3010673850
- 1222773
- 3010673777
- 3015231789
- 1124621
- 1000517406
- 3005061536
- 3025141
- 3016112537
- 3013011598
- 3021336182
- 3010383847
- 1319660
- 1048735
- 2648666
- 2530154
- 3030655570
- 3001592626
- 3017191784
- 3014527928
- 3035366890
- 3015131017
- 3006694268
- 3012966183
- 3013302242
- 1226544
- 3009417901
- 3003418325
- 9613369
- 3008868758
- 1017294
- 3010470577
- 3031240334
- 2028632
- 3009973336
- 3010329663
- 2431166
- 3007923096
- 1643264
- 3015151147
- 1649518
- 3013680140
- 2031093
- 1221053
- 1833506
- 3014252644
- 1818910
- 9681465
- 3006395932
- 3000270450
- 3038503932
- 3010041499
- 3015895045
- 3027242374
- 3008114965
- 1054811
- 2249529
- 1000461041
- 3014262693
- 3004993707
- 3007366790
- 1828288
- 3006498370
- 3020745223
- 3009746186
- 3022142628
- 3010178296
- 3022518322
- 2183785
- 1018470
- 3008951116
- 3010162973
- 3017196117
- 3014004349
- 9680825
- 1649390
- 3009540749
- 3002807315
Source Documents#
Other 510(k) Records For Product Code HTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 |
Legacy Summary#
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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