510(k) K230071
- Device
- Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
- Applicant
- Tdm Co., Ltd.
- 510(k) number
- K230071
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-22
- Date received
- 2023-01-10
- Regulation
- 888.3020
- Classification name
- Rod, Fixation, Intramedullary And Accessories
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jung Wook Choi
- Address
- 69, Cheomdan Venture So-Ro 37 Beon-Gil Buk-Gu KR 61003 61003
FDA Registration Numbers#
- 3010097171
- 3014302784
- 3015216945
- 3015882686
- 3010502940
- 3001239363
- 2031966
- 3006001176
- 1424263
- 3007597023
- 3004638532
- 3015183635
- 1422572
- 3003761012
- 3010220595
- 1043534
- 3035366890
- 3015869492
- 3007420745
- 1935627
- 1825034
- 9613910
- 3010106508
- 3008749819
- 3010440433
- 3015806723
- 3015207155
- 3043543260
- 3009971621
- 3011302692
- 3015440604
- 3010120104
- 3007913880
- 3006846433
- 3010041430
- 3017521423
- 3006849754
- 3010178296
- 3004358587
- 3026311512
- 3006513362
- 3009532798
- 3007344102
- 3016237080
- 3016261131
- 3025141
- 3009455196
- 1722511
- 3006563559
- 1058584
- 1054811
- 9616944
- 3008102042
- 3038503932
- 3004450489
- 3009144915
- 2183449
- 3010606097
- 3002807295
- 3011127597
- 3030926959
- 3008198024
- 3010370500
- 3011388423
- 1043653
- 3010287665
- 2249697
- 3009756327
- 3014004349
- 1833920
- 2183946
- 3010057495
- 3003108161
- 9710312
- 3008812251
- 1835296
- 9611390
- 3003249380
- 1649390
Source Documents#
Other 510(k) Records For Product Code HSB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026-06-29 |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | 2026-06-18 |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026-06-18 |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | 2026-05-19 |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026-05-08 |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026-04-24 |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | 2026-03-20 |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026-03-18 |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | 2026-03-12 |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | 2026-03-10 |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026-03-05 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | 2026-03-04 |