510(k) K241014
- Device
- Biomet Kirschner Wires (K-Wires)
- Applicant
- Biomet, Inc.
- 510(k) number
- K241014
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-22
- Date received
- 2024-04-12
- 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
- Akash Savalia
- Address
- 56 E. Bell Dr., P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3014302784
- 3004638532
- 2530154
- 3025266
- 3011301313
- 1424263
- 1043534
- 3035366890
- 3007420745
- 3040335671
- 1825034
- 9613910
- 3008749819
- 3015806723
- 3012818475
- 3021393544
- 3015207155
- 3009971621
- 3011302692
- 3015440604
- 3022518322
- 3014252644
- 3005180920
- 3019356409
- 3003236702
- 3007109793
- 3010178296
- 2431166
- 3006513362
- 3012770122
- 3025141
- 1054811
- 1058584
- 3011137372
- 9616944
- 3005641619
- 3008102042
- 3030655570
- 3038503932
- 1124621
- 3014286836
- 2183449
- 3014680795
- 1226183
- 3002807295
- 3011127597
- 1017294
- 3010370500
- 3022472578
- 1043653
- 3014004349
- 1833920
- 2183946
- 1319660
- 3008812251
- 3003755939
- 1649390
- 1220246
- 3013011598
- 3008817603
- 2028632
- 3017196117
- 3008559295
- 3010041511
- 3009631939
- 3013176080
- 3004748528
- 3009513193
- 3008868758
- 3014527928
- 3003604053
- 2032098
- 3011656326
- 3006498370
- 3002949614
- 3015542154
- 1833506
- 3006742481
- 3027339877
- 3014170143
Source Documents#
Other 510(k) Records For Product Code HTY#
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|---|---|---|---|
| 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 |
| 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 |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | 2021-09-30 |