510(k) K022597
- Device
- K-FIX
- Applicant
- NEWDEAL S.A.
- 510(k) number
- K022597
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-01
- Date received
- 2002-08-05
- 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
- NORMAN F ESTRIN
- Address
- 9109 Copenhaver Dr. Potomac MD US 20854 20854
FDA Registration Numbers#
- 3021393544
- 1032347
- 3004464325
- 1226191
- 1833506
- 1836357
- 3012883081
- 1226544
- 3003236702
- 3013302242
- 3008812560
- 1220477
- 3015895045
- 1828464
- 3015709929
- 9611274
- 1221934
- 3014314623
- 1421101
- 1043534
- 3027553380
- 3017191784
- 3006638824
- 3010331645
- 3021226419
- 3009554293
- 3007993775
- 3012103978
- 3027339877
- 1124621
- 3012358417
- 3006801265
- 9680619
- 3008749819
- 3019269298
- 3022518322
- 3015151147
- 3010673777
- 3014262693
- 1835572
- 3003604053
- 3013700547
- 1818910
- 3025266
- 3005180920
- 2183946
- 3027242374
- 3002949614
- 3015440604
- 9616696
- 3013055499
- 3016438694
- 3015212339
- 3007420745
- 1824313
- 1018470
- 3009826895
- 3003418325
- 2437731
- 2031093
- 3011656326
- 3005809810
- 3008793310
- 3010470577
- 3012770122
- 3026032087
- 3014170143
- 8030965
- 2245304
- 3011302692
- 3005536892
- 3009973336
- 3009732568
- 3015542154
- 3004961578
- 8010468
- 3012755988
- 3007109793
- 3010383847
- 3022142628
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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