510(k) K150655
- Device
- OIC Intramedullary Nail System
- Applicant
- ORTHOPAEDIC IMPLANT COMPANY
- 510(k) number
- K150655
- Product code
- HSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-09
- Date received
- 2015-03-13
- 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
- Douglas Fulton
- Address
- 316 California Ave. #701 Reno NV US 89509 89509
FDA Registration Numbers#
- 3004369035
- 1935627
- 3010047454
- 3015869121
- 3004464325
- 3006639944
- 3010068573
- 2134947
- 1833506
- 3006849754
- 3014967149
- 1226544
- 3003935342
- 3013302242
- 3008812560
- 1220477
- 1828464
- 3004049923
- 3030714745
- 3009158523
- 3016237080
- 3014314623
- 1043534
- 3019767615
- 3003108161
- 2031966
- 3010331645
- 3009116370
- 3015216945
- 3009554293
- 3007993775
- 3027339877
- 2953359
- 3006801265
- 3005497913
- 3010386387
- 3010411051
- 3004513872
- 3008749819
- 3003898228
- 3019269298
- 3000327445
- 1818910
- 1835572
- 3006487372
- 3006846433
- 3012724179
- 3026776
- 2183946
- 2022435
- 3002949614
- 3011388423
- 3015440604
- 3013055499
- 3005144609
- 3006563559
- 1051526
- 3016438694
- 3048284429
- 3015212339
- 3010041430
- 3005581234
- 1424434
- 3015882686
- 3007420745
- 3008599979
- 1529009
- 3002962587
- 3004450489
- 3010470577
- 3008791302
- 3015869492
- 3010440433
- 9710312
- 3014170143
- 3004153896
- 8030965
- 9613350
- 3007344102
- 3011302692
Source Documents#
Other 510(k) Records For Product Code HSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026-09-24 |
| 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 |
Legacy Summary#
summary
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