510(k) K210285
- Device
- Adaptable Ortho Innovations Intramedullary Nail System
- Applicant
- Adaptable Ortho Innovations, LLC
- 510(k) number
- K210285
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-18
- Date received
- 2021-02-02
- 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
- Steve Palin
- Address
- 65 Main St. Potsdam NY US 13676 13676
FDA Registration Numbers#
- 2183449
- 3006487372
- 3007593722
- 3021008900
- 3030412764
- 2183946
- 1060840
- 3005290844
- 3014967969
- 3013176080
- 3009973699
- 3015876273
- 1423662
- 3009756327
- 3011534620
- 3008951116
- 3006460162
- 1834379
- 3009998573
- 9615128
- 3014170143
- 1833506
- 3018011420
- 3012724179
- 3014302784
- 3008198024
- 1526534
- 3009971621
- 1643264
- 3009455196
- 3010106508
- 3007441485
- 3010400367
- 3014257776
- 2031009
- 3008868758
- 1835296
- 9613350
- 3004464325
- 3043543260
- 1226544
- 8010177
- 3005874553
- 3010606097
- 3005581234
- 3006849754
- 3003541440
- 3010363503
- 3010120104
- 3016727307
- 2134947
- 3015882686
- 3014315669
- 3006001176
- 1835572
- 3003477135
- 3009973505
- 3009532798
- 3013756169
- 1051526
- 1935627
- 1721676
- 1220477
- 1835444
- 3015542154
- 3005061536
- 3010440433
- 3014976005
- 1221763
- 3007913880
- 1058584
- 3006563559
- 3010386387
- 3005059805
- 3011053036
- 3006217744
- 3015806723
- 9680825
- 3008812251
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases