510(k) K071863
- Device
- ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)
- Applicant
- BIORETEC LTD
- 510(k) number
- K071863
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-08-31
- Date received
- 2007-07-06
- 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
- MARI RUOTSALAINEN
- Address
- Hermiakatu 22 Modulight Bldg Tampere FI FI-33720 FI-33720
FDA Registration Numbers#
- 2183449
- 3021008900
- 2183946
- 3042285592
- 3013176080
- 3009973699
- 3010673850
- 1423662
- 3015967359
- 3004893332
- 3007109793
- 1421101
- 2025102
- 9616696
- 3006460162
- 3008951116
- 1221934
- 3002807315
- 3014170143
- 1833506
- 3015974593
- 3014262693
- 3012818475
- 3014302784
- 1526534
- 3009971621
- 3010400367
- 1643264
- 3011302058
- 3002806470
- 3009110133
- 3006524618
- 3002579136
- 9613369
- 2031009
- 3008868758
- 3017196117
- 3004464325
- 3042903229
- 1226544
- 8010177
- 3020745223
- 1320894
- 3016727307
- 1824313
- 3008793310
- 3014315669
- 1226183
- 2245304
- 1221053
- 1835572
- 3003477135
- 3001592626
- 3009973505
- 3011656326
- 3012883081
- 3015131017
- 3015453963
- 1220477
- 3005061536
- 3015542154
- 2183785
- 3019356409
- 3004961578
- 1058584
- 2183967
- 3026032087
- 9680825
- 3015806723
- 3008812251
- 3009513193
- 1836357
- 3031240334
- 8043792
- 3002807310
- 1020279
- 3006513362
- 3002949614
- 1828288
- 3010178296
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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