This page includes the latest FDA filings for Orthopedic Designs North America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 1064129 |
| FEI Number | 3002684506 |
| Name | Orthopedic Designs North America, Inc. |
| Owner & Operator | Orthopedic Designs North America, Inc. |
| Contact Address | 5912 Breckenridge Parkway Suite F Tampa FL 33610 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 5912 Breckenridge Parkway Suite F Tampa, FL 33610 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-11-C10-L | 2025-02-05 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-11-C05-L | 2025-02-05 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-11-C00-L | 2025-02-05 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-068 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-064 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-060 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-056 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-052 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-048 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-046 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-044 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-042 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AS-5-040 | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-240R | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-240L | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-225R | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-225L | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-210R | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-210L | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-180R | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Atlas™ Humeral Nail System AHN-08-180L | 2025-01-22 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-095NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-090NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-085NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-080NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-075NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-070NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-065NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-060NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-055NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-050NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-75-16-045NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-09-15NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Cannulated Compression Device (CCD) System CCD-09-12NS | 2024-07-29 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-120NS | 2024-07-26 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-115NS | 2024-07-26 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-110NS | 2024-07-26 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-105NS | 2024-07-26 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-100NS | 2024-07-26 |
| Orthopedic Designs North America, Inc. | Torque Limiting Handle SLN-T05 | 2024-07-22 |
| Orthopedic Designs North America, Inc. | Torque Limiting Handle ODI-U07 | 2024-07-22 |
| Orthopedic Designs North America, Inc. | Torque Limiting Handle ODI-T144 | 2024-07-22 |
| Orthopedic Designs North America, Inc. | Retractor Driver ODI-T142 | 2024-07-22 |
| Orthopedic Designs North America, Inc. | Torque Limiting Handle ODI-T119 | 2024-07-22 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-095NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-090NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-085NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-080NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-075NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-070NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-065NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-060NS | 2023-09-06 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-055NS | 2023-09-04 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-050NS | 2023-09-04 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-045NS | 2023-09-04 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-040NS | 2023-09-04 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-035NS | 2023-09-04 |
| Orthopedic Designs North America, Inc. | Talon™ DistalFix™ ART Cortical Screw ART-5-030NS | 2023-09-04 |
| Orthopedic Designs North America, Inc. | Lag Driver SLN-T30 | 2023-08-23 |
| Orthopedic Designs North America, Inc. | Lag Driver Connector Screw SLN-T24 | 2023-08-23 |
| Orthopedic Designs North America, Inc. | Lag Guide Sleeve SLN-T23 | 2023-08-23 |
| Orthopedic Designs North America, Inc. | Lag Talon Retractor Driver SLN-T13 | 2023-08-23 |
| Orthopedic Designs North America, Inc. | Screw Sleeve ODI-T104 | 2023-08-23 |
| Orthopedic Designs North America, Inc. | Screw Sleeve ODI-F13 | 2023-08-23 |
| Orthopedic Designs North America, Inc. | Lag Guide Pin Obturator SLN-T22 | 2023-08-21 |
| Orthopedic Designs North America, Inc. | Trocar ODI-T106 | 2023-08-21 |
| Orthopedic Designs North America, Inc. | Trocar ODI-F15 | 2023-08-21 |
| Orthopedic Designs North America, Inc. | Guide Wire Pusher SLN-T40 | 2023-07-17 |
| Orthopedic Designs North America, Inc. | Guide Wire Obturator SLN-T32 | 2023-07-17 |
| Orthopedic Designs North America, Inc. | Exchange Tube SLN-T44 | 2023-07-14 |
| Orthopedic Designs North America, Inc. | Guide Wire Introducer SLN-T21 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Driver Connector Screw ODI-U02 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Flex Anchor Retraction Driver ODI-T143 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Driver Shaft ODI-T141 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Dual End Drill Guide ODI-T139 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Compression Nut Driver ODI-T136 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Drill Sleeve ODI-T105 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Drill Sleeve ODI-F14 | 2023-07-10 |
| Orthopedic Designs North America, Inc. | Talon DistalFix Nail Instrument Tray SLN-T50 | 2023-07-07 |
| Orthopedic Designs North America, Inc. | CCD Instrument Tray ODI-T145 | 2023-07-07 |
| Orthopedic Designs North America, Inc. | Talon DistalFix Removal Tray ODI-T131 | 2023-07-07 |
| Orthopedic Designs North America, Inc. | Talon DistalFix Humeral Nail Instrument Tray ODI-T127 | 2023-07-07 |
| Orthopedic Designs North America, Inc. | Talon DistalFix A/R Femoral Nail Instrument Tray ODI-F100 | 2023-07-07 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-130 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-125 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-120 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-115 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-110 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-105 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-100 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-095 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head SLN-T02-090 | 2023-07-05 |
| Orthopedic Designs North America, Inc. | Lag Guide Pin Depth Gauge SLN-T18 | 2023-07-04 |
| Orthopedic Designs North America, Inc. | Modular Flexible Reamer Shaft SLN-T01 | 2023-07-04 |
| Orthopedic Designs North America, Inc. | Depth Gauge ODI-T138 | 2023-07-04 |
| Orthopedic Designs North America, Inc. | Screw Depth Gauge ODI-T126 | 2023-07-04 |
| Orthopedic Designs North America, Inc. | Compressor ODI-T110 | 2023-07-03 |
| Orthopedic Designs North America, Inc. | Cortical Drill ODI-T109 | 2023-07-03 |
| Orthopedic Designs North America, Inc. | Cortical Drill ODI-F16 | 2023-07-03 |
| Orthopedic Designs North America, Inc. | Compressor ODI-F10 | 2023-07-03 |
Orthopedic Designs North America, Inc. | Cannulated Compression Device System | 2022-04-13 |
Orthopedic Designs North America, Inc. | Talon DistalFix Humeral Nail | 2018-03-08 |
Orthopedic Designs North America, Inc. | Talon DistalFix Humeral Nail | 2018-02-22 |
Orthopedic Designs North America, Inc. | Impactor | 2015-12-29 |
Orthopedic Designs North America, Inc. | Proximal Reamer | 2015-12-29 |
Orthopedic Designs North America, Inc. | Modular Reamer Cutter Head | 2015-12-29 |
Orthopedic Designs North America, Inc. | Modular Flexible Reamer Shaft | 2015-12-29 |
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. | Talon DistalFix Antegrade/Retrograde Femoral Nail | 2015-11-03 |
Orthopedic Designs North America, Inc. | Trocar | 2013-12-20 |
Orthopedic Designs North America, Inc. | Torque Wrench (Demo Handle) | 2013-12-20 |
Orthopedic Designs North America, Inc. | Torque Limiting Handle | 2013-12-20 |
Orthopedic Designs North America, Inc. | Tissue Protector | 2013-12-20 |
Orthopedic Designs North America, Inc. | Talon DistalFix Nail Targeting Guide | 2013-12-20 |
Orthopedic Designs North America, Inc. | Talon DistalFix Nail Instrument Tray | 2013-12-20 |
Orthopedic Designs North America, Inc. | Talon DistalFix Humeral Nail Instrument Tray | 2013-12-20 |
Orthopedic Designs North America, Inc. | T25 Driver | 2013-12-20 |
Orthopedic Designs North America, Inc. | T-Handle Pin Puller | 2013-12-20 |
Orthopedic Designs North America, Inc. | Slotted Slap Hammer | 2013-12-20 |
Orthopedic Designs North America, Inc. | Slide Hammer | 2013-12-20 |
Orthopedic Designs North America, Inc. | Screw Sleeve | 2013-12-20 |
Orthopedic Designs North America, Inc. | Ratcheting Axial Handle | 2013-12-20 |
Orthopedic Designs North America, Inc. | Nail-Handle Connector Screw | 2013-12-20 |
Orthopedic Designs North America, Inc. | Nail Talon Deployment Driver | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Talon Retractor Driver | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Talon Deployment Driver | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Guide Sleeve | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Guide Pin | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Guide Pin Obturator | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Driver | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Driver Connector Screw | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Drill | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Drill Stop | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Alignment Plug | 2013-12-20 |
Orthopedic Designs North America, Inc. | Knob Wrench | 2013-12-20 |
Orthopedic Designs North America, Inc. | Impactor / Extractor | 2013-12-20 |
Orthopedic Designs North America, Inc. | Hex Driver 5 & 7mm | 2013-12-20 |
Orthopedic Designs North America, Inc. | Handle-Arm Connector Screw | 2013-12-20 |
Orthopedic Designs North America, Inc. | Guide Wires (Trocar, Round, Ball Tip - 280mm, 600mm & 900mm) | 2013-12-20 |
Orthopedic Designs North America, Inc. | Guide Wire Pusher | 2013-12-20 |
Orthopedic Designs North America, Inc. | Guide Wire Obturator | 2013-12-20 |
Orthopedic Designs North America, Inc. | Guide Wire Introducer | 2013-12-20 |
Orthopedic Designs North America, Inc. | Guide Handle | 2013-12-20 |
Orthopedic Designs North America, Inc. | Guide Arm | 2013-12-20 |
Orthopedic Designs North America, Inc. | External Compressor | 2013-12-20 |
Orthopedic Designs North America, Inc. | Exchange Tube | 2013-12-20 |
Orthopedic Designs North America, Inc. | Drill Sleeve | 2013-12-20 |
Orthopedic Designs North America, Inc. | Drill Bit | 2013-12-20 |
Orthopedic Designs North America, Inc. | Curved Entry Awl | 2013-12-20 |
Orthopedic Designs North America, Inc. | Ball Tip Sheathed Guide Wire (600mm & 900mm) | 2013-12-20 |
Orthopedic Designs North America, Inc. | Screw Depth Gauge | 2013-12-20 |
Orthopedic Designs North America, Inc. | Radiographic Talon Template | 2013-12-20 |
Orthopedic Designs North America, Inc. | Lag Screw Guide Pin Ruler | 2013-12-20 |
Orthopedic Designs North America, Inc. | Folding Nail Guide Wire Ruler | 2013-12-20 |
Orthopedic Designs North America, Inc. | Talon DistalFix Proximal Femoral Nail | 2012-12-10 |
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. | TALON DISTALFIX PROXIMAL FEMORAL NAIL | 2011-08-22 |
Orthopedic Designs North America, Inc. | ODI Ultimate Compression Hip Screw | 2010-01-25 |
Orthopedic Designs North America, Inc. | ODI Talon Long Prox Fem Nail Sys | 2010-01-25 |
Orthopedic Designs North America, Inc. | ODI 7.0mm Cannulated Screw System | 2010-01-25 |
Orthopedic Designs North America, Inc. | ODI Talon Intramedullary Hip Nail | 2010-01-25 |
| SEC | 0001500062 | ORTHOPEDIC DESIGNS NORTH AMERICA, INC. of FLORIDA |