510(k) K052736
- Device
- ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
- Applicant
- ARTHREX, INC.
- 510(k) number
- K052736
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-03
- Date received
- 2005-09-30
- 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
- ANN WATERHOUSE
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3020745223
- 1649518
- 3010370500
- 3015967359
- 3017196117
- 2025102
- 3009423112
- 3005809810
- 3010329663
- 3006694268
- 3020704423
- 3006742481
- 3011500362
- 3015974593
- 3006498370
- 1124621
- 1061927
- 2028632
- 3022518322
- 1018470
- 3006783837
- 3012883081
- 3008729892
- 3001592626
- 1833506
- 1824313
- 2245304
- 1835831
- 3006513362
- 3009631939
- 1043534
- 3010162973
- 3012329552
- 3013680140
- 3019455
- 3014170143
- 3021336182
- 1054811
- 3025603301
- 3005641619
- 2936485
- 3015946784
- 3015806723
- 3014262693
- 3011301313
- 3009826895
- 3010673850
- 3002806470
- 3030183061
- 3012755988
- 3034676720
- 9616696
- 9681465
- 3004638532
- 3008951116
- 1833986
- 3002807310
- 3010041511
- 3013011598
- 3015131017
- 3022142628
- 3011127597
- 3042285592
- 3004961578
- 3011302058
- 3012103978
- 3007420745
- 3007923096
- 3015207155
- 3006524618
- 3012818475
- 1043653
- 3014129047
- 3011302692
- 3009554293
- 3002949614
- 3015539532
- 1643264
- 3008650117
- 1000517406
Source Documents#
Other 510(k) Records For Product Code HTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022-02-17 |
Legacy Summary#
summary
FDA Review#
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