510(k) K163014
- Device
- AOS Small Bone Nailing System
- Applicant
- Advanced Orthopaedic Solutions, Inc. (AOS)
- 510(k) number
- K163014
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-01-24
- Date received
- 2016-10-28
- 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
- Alex Bhaskarla
- Address
- 3203 Kashiwa St. Torrance CA US 90505 90505
FDA Registration Numbers#
- 1000517406
- 3034525
- 3010065126
- 3009381600
- 8030965
- 3006125668
- 3006846433
- 3010041430
- 3015212339
- 3006846753
- 3006513362
- 3015216945
- 3010047454
- 8031020
- 3009971621
- 3007420745
- 3003108161
- 2134947
- 3006946279
- 3015542154
- 3010120104
- 3013176080
- 3013820441
- 3015440604
- 3014315669
- 1835572
- 3036756245
- 3004142400
- 1226544
- 1220246
- 3010363503
- 1835251
- 1834331
- 1834379
- 3043543260
- 3004638532
- 9611813
- 3015946784
- 1043534
- 1220477
- 2028632
- 3008951116
- 3010364775
- 3015869121
- 3006395932
- 3000270450
- 3009144915
- 3014273424
- 1058584
- 3012392319
- 3010502940
- 2183946
- 3011500362
- 3011302692
- 3012663306
- 3017521423
- 3010386387
- 3020704423
- 1054811
- 9617297
- 3048284429
- 1020279
- 3015231789
- 3004513872
- 1835444
- 3005290844
- 3014315560
- 3004369035
- 1051526
- 3009189869
- 2032098
- 3007913880
- 3026311512
- 3006017180
- 3006742481
- 3010057495
- 3031261833
- 2134285
- 3008650117
- 3003249380
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 |
Legacy Summary#
summary
FDA Review#
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