510(k) K041288
- Device
- MODIFICATION TO SMARTPIN
- Applicant
- LINVATEC BIOMATERIALS, INC.
- 510(k) number
- K041288
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-06-10
- Date received
- 2004-05-13
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TUIJA ANNALA
- Address
- P.O. Box 3 Hermiankatu 6-8l Tampere FI FIN-33720 FIN-33720
FDA Registration Numbers#
- 2936485
- 2183946
- 3009189869
- 3016851379
- 1649390
- 3013055499
- 3016112537
- 3021008900
- 2020601
- 9616696
- 3010041511
- 3010370500
- 3016438694
- 3004638532
- 9681465
- 3005536892
- 1720747
- 1450662
- 1222773
- 3027553380
- 3010400367
- 3008114965
- 3010041499
- 3006801265
- 3004215117
- 3022518322
- 3013011598
- 3014252644
- 3008868758
- 3010389204
- 1226183
- 1061927
- 3010863450
- 1032347
- 9611274
- 3009631939
- 3004993707
- 3015212339
- 3006524618
- 3025266
- 2249615
- 2437731
- 3008812560
- 1000461041
- 2025102
- 1833920
- 3003604053
- 3030655570
- 3020704423
- 1221053
- 3009971621
- 3011137372
- 3009381600
- 3010673777
- 1226191
- 3006272282
- 3005809810
- 3013176080
- 3005641619
- 1054811
- 3008102042
- 3015974593
- 1836357
- 3006513362
- 3007130914
- 3014262693
- 3011580264
- 3002806470
- 8043792
- 3038503932
- 3015539532
- 3014680795
- 3005061536
- 3016496998
- 1834331
- 1221934
- 3009513193
- 3009110133
- 3020899789
- 3030183061
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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